The effect of giving a Drug to block nerves supplying Kidneys to reduce Blood loss during Surgery for removal of Kidney Stones.
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2020/09/027909
- Lead Sponsor
- RajaRajeswari Medical College and Hospital
- Brief Summary
**Title of the project****:** Effect of Paravertebral Block on reducing bloodloss in Percutaneous Nephrolithotomy (PCNL)surgeries : Randomized Controlled Trial.
Dr Rashmi, Assistant professor, Department of anesthesiology and criticalcare, RRMCH, Bangalore
Dr. Shankar K, Assistant professor, Department of anesthesiology and Criticalcare, RRMCH, Bangalore
**NEED FOR STUDY**
Percutaneous nephrolithotomy(PCNL) is a minimally invasive urologicalprocedure done as treatment for kidney stones greater than 20mm or incircumstances where kidney stones are not broken by extra corpororeal shockwave lithotripsy1. The extraction of stones is done percutaneouslythrough a small incision leading to lesser morbidity and shortens hospital stay2.
Bleeding is one of the majorcomplication associated with percutaneous nephro lithotomy. Pelvicalycealsystem is opened up and intrarenal manipulations can cause injury to the renalvasculature, especially the interlobar and segmental arteries3.
Creating multiple tracts, diabetes, prolonged duration of surgery areassociated with increased blood loss4.
Methods like use of tranexamic acid and Mini percutaneous nephrolithotomyvia small percutaneous tract (11- 20 F) have been used to reduce blood loss butthe results are inconclusive5,6.
Paravertebral block with local anesthetics causes sympathetic nerveblock with reduces the pressures in the regional vasculature, decreases neuroendocrine stress response and there by reducing the blood loss 7.
Hence we are conducting this study to see the effectof unilateral paravertebral block given beforesurgery to reduce intra operative blood loss.
**REVIEW OF LITERATURE:**
**Kukreja** et al in 2004 did a study to determine factorsaffecting blood loss during percutaneous nephrolithotomy .It was a prospectivestudy which concluded preoperative hemoglobin , multiple tracts , stone size,and total blood loss were significant in predicting blood transfusionrequirement. Factors such as age, hypertension, renal insufficiency , urinarytract infection, the degree of hydronephrosis, stone bulk and function ofipsilateral kidney did not have anyaffect on blood loss4.
**Said** et al in 2016reviewed factors affecting total blood loss and need for blood transfusion in aseries of patient undergoing unilateral percutaneous nephrolithostomy. Itshowed factors which affecting rate of blood transfusion were intraoperative complications like perforationand extravasation, stone complexity, operative time and preoperative creatininelevel8.
**Syahputra** et al in 2016 conducted a study on blood loss predictive factors and transfusionpractice during percutaneous nephrolithostomy of kidney stones. It was aprospective randomised study which determined stone burden as major predictorof blood loss3.
**Meng et al** in 2019 analysed the risk factors for heamorrhage associated withminimally invasive percutaneous nephrolithostomy. Retrospective analysis determinedthat surgeons experience, stone size, staghorn calculi, operation time wererisk factors for bleeding intraoperatively9.
**Mohammadi** et al in 2019 studied effect of tranexamic acid onbleeding and hemoglobin levels in patients with staghorn calculi undergoingpercutaneous nephrolithotomy. This randomised controlled trial concluded thattranexamic acid reduced risk of bleeding and attenuated the drop in thehemoglobin level5.
**AIM:** To assess the efficacy of USG guidedunilateral paravertebral block for reduction of blood loss in PCNL surgeries
**Objectives –**
• Comparison of hemodynamic parameters.
• To study the safety profile of abovetechniques and the drugs used.
**MATERIALSAND METHODS****:**
A) **Study design**: Randomized control trial
B)**Study period**:3 month
B) **Place ofstudy**: Inpatients at hospitals attached toRajarajeswari Medical College and hospital, Bangalore.
C) **Sample size**: Afterconducting a pilot study average drop in the hemoglobin in was 2.5g/dl and 0.83g/dl in control group andparavertebral group respectively. Considering effect size as 1.6, alpha erroras 0.05 and power of 80%, 23 patients per group was obtained. To avoid studyattrition and errors 25 patients per group was taken up for study.
**E) Inclusion Criteria:**
1. Adult patients between 18-60yr of age ofeither sex.
2. ASA status Iand II
3. Undergoingunilateral PCNL surgeries.
**F)Exclusion Criteria:**
1. Patientsrefusing to participate in the study
2. Patient withuncontrolled hypertension, diabetes, cardio-respiratory disorders,neuro-psychiatric disorders, hepatic or renal dysfunction.
3.Coagulopathy, infection at the site of block, neurological deficits.
4. Patients onmedications like opioids, sedatives, anti-psychotics, anti-epileptics.
5. Pregnant orlactating mothers.
6.Alcoholic
7.Allergic tostudy drug
**Methodology of Study:**
Following approval of institutional ethical committee50 patients will be taken up for the study after testing negetive for COVID 19.Pre anesthetic evaluation will be done for all the patients and preoperativehemoglobin will be noted. Written informed consent will be taken. All patientswill be kept nil per oral for 8hrs.
In operation theatre standardmonitors will be attached and baseline parameters will be recorded. Thepatients are randomized with help of sealed opaque envelope technique into twogroups. Group C is taken as control group and Group P will receive ultrasoundguided unilateral paravertebral block.
In group P, paravertebral block will be performed in sitting position underultrasound guidance with 22G echogenic needle after identifying the landmarksat the T10-T11 levelsusing 20 ml of 0.375% ropivacaine. Thespread of the local anaesthetic will be confirmed by anterior movement of thepleura in the paravertebral space.
In the control group, no intervention was performed.All blocks will be performed by the same experienced anesthesiologist.
Patient will be placed in supine position andpremedicated with Injection midazolam 0.02mg/kg, glycopyrrolate 0.005mg/kg, andfentanyl 1-2mcg/kg 5min before induction. After pre oxygenation with 100% O2for 3-5min, patient will be induced with injection of propofol 2-2.5mg/kg tillthe loss of verbal commands. Neuromuscular blockade to facilitate placement ofendotracheal tube will be achieved by injection vecurronium 0.08-0.1mg/kg. Anaesthesia will be maintained with oxygen,nitrous oxide, isoflurane, and vecuronium. After the insertion of a urinary catheter, the patientswill be placed in the prone position for the surgery. Hemodynamicswill be monitored throughout the surgery. The patient will be placed back insupine position after completion of surgery, extubated after meeting theexubation criteria and shifted to post anesthesia care unit for monitoring.
Repeat hemoglobin will be performed 24 hours aftersurgery.
**STATISTICAL ANALYSIS**
Samplesize estimation: After conducting a pilot study average drop in thehemoglobin in was 2.5g/dl and 0.83g/dl in control group and paravertebral grouprespectively. Considering effect size as 1.6, alpha error as 0.05 and power of80%, 23 patients per group was obtained. To avoid study attrition and errors 25patients per group was taken up for study.
Statisticalanalysis will be done using SSPS software 16 version as follows:
Student T test will beused to compare nominal data between the groups.
Chi square test will beused to compare categorical data between the groups.
P value <0.05 willbe considered significantly.
**DOESTHE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED ONPATIENTS OR OTHERS HUMANS OR ANIMALS? IF SO, PLEASE DESCRIBE BRIEFLY**
The study doesn’trequire any intervention on animals.
Routineinvestigations relevant for surgery - Complete blood count, RBS, RFT, serumelectrolytes, ECG, chest X ray.
**LISTOF REFERENCES:**
1. Gupta M, Ost MS, Shah JB, et al. Percutaneousmanagement of upper urinary tract. In Wein AJ, et al (eds). Campbell WalshUrology, 9th ed. Philadelphia, Saunders Elsevier, 2007.
2.Carrion D, Cancino J R,Quintana L M, et al: Prone percutaneous nephro lithotomy: its advantage and ourtechnique for puncture. Transl Androl Urol. 2018 Dec; 7(6):950-959
3. Syahputra FA, Birowo P,Rasyid N, Matondang FA, Noviandrini E, Huseini MH. Blood loss predictivefactors and transfusion practice during percutaneous nephrolithotomy of kidneystones: a prospective study. *F1000Res*. 2016;5:1550. Published 2016 Jun30. doi:10.12688/f1000research.8993.
4. Kukreja R, Desai M, Patel S, Bapat S, Desai M. Factorsaffecting blood loss during percutaneous nephrolithotomy: Prospective study. J Endourol. 2004;18:715–722. doi:10.1089/0892779042360599.
5. Mohammadi Sichani M, KazemiR, Nouri-Mahdavi K, Gholipour F. **Re-evaluationof the efficacy of tranexamic acid in reducing blood loss in percutaneousnephrolithotomy: a randomized clinical trial.**Minerva Urol Nefrol. 2019;71(1):. <https://doi.org/10.23736/S0393-2249.18.03151-X>
6. Ferakis N, Stavropoulos M.Mini percutaneous nephrolithotomy in the treatment of renal and upper ureteralstones: Lessons learned from review of the literature. Urol Ann. 2015 Apr-Jun;7(2): 141-148
7. Batra RK, Krishnan K,Agarwal A. Paravertebral block. J Anaesthesiol Clin Pharmacol.2011 Jan-Mar;27(1):5-11.
8. Said S, Aghaways I, FryadG. Review of factors affecting total blood loss and need for blood transfusionin a series of patient undergoing unilateral percutaneous nephrolithotomy. UrolNephrol Open Access J. 2016;3(6):208-213
9. Meng X, Bao J, Mi Q et al:The analysis of risk factors for heamorrhage associated with minimally invasivepercutaneous nephrolithostomy.
| |
| --- |
|BioMed Research International. 2019;2019:1. <https://doi.org/10.1155/2019/8619460>
**CERTIFICATE**
Thedissertation topic “**Effect of paravertebral block on reducing bloodloss in percutaneous nephrolithotomy(PCNL) surgeries : Randomized controlledtrial****â€**
AtRajarajeshwari Medical College and Hospital, Bangalore by Dr. Priyanka D ,post-graduate student in the Department of Anesthesiology has been approved bythe institutional ethical committee, RAJARAJESWARI MEDICAL COLLEGE, BANGALORE.
**INFORMED CONSENT**
I, Dr. Rashmi, Assistant professor, Department of anaesthesiaconducting a randomized trial for award of MD degree in Anaesthesia. The topic of thestudy is: “**Determining effectiveness ofparavertebral block on blood loss inpercutaneous nephrolithotomy surgeries : a randomized controlled trial****â€**
I have been briefedon the foregoing research being conducted by Dr. Rashmi and it has beenconveyed to me in my own language .I have had the opportunity to ask questionsabout it & all questions that I have asked have been answered to mysatisfaction. I consent voluntarily to participate as a participant in thisresearch & understand that I have the right to withdraw from the researchat any time without in any way affecting my medical care.
Name of theparticipant:.......................................................................................... Signature of theparticipant: ..........................................................................................Date:(d/m/y).......................................................................................
If illiterate: A literate witnessmust sign ( If possible this person should be selected by the
participant andshould have no connection to the research team)I have read and witnessed theaccurate reading of the consent form to the potential participant and theindividual has had the opportunity to ask questions, I confirm that theindividual has given consent freely.
Name of thewitness................................................... Signature ofwitness.............................................. Date:(d/m/y)....................................................
Thumb impression ofparticipant
I have read andwitnessed the accurate reading of the consent form to the potential participantand the individual has had the opportunity to ask questions, I confirm that theindividual has given consent freely. In case of any doubt I have been asked tocontact: Dr. Rashmi, assistant professor indepartment of anaesthesiology
Name ofResearcher:...............................................................Signature of researcher:............................................................
Date :(d/m/y)........................................................................
**ತಿಳಿವಳಿಕೆಯà³à²³à³à²³ ಸಮà³à²®à²¤à²¿à²¨à²®à³‚ನೆ.**
**ನಾನà³, ಅರಿವಳಿಕೆ ಸà³à²¨à²¾à²¤à²•à³‹à²¤à³à²¤à²°à²µà²¿à²à²¾à²—ದ** ಡಾ RASHMI **ಅರಿವಳಿಕೆ ವಿಷಯದಲà³à²²à²¿à²¨** **‘****ಡಾಕà³à²Ÿà²°à³ ಆಫೠಮೆಡಿಸನà³****‌****‘****(ಎಂಡಿ) ಪದವಿಗಾಗಿ ನಡೆಸà³à²¤à³à²¤à²¿à²°à³à²µ****ಯಾದೃಚà³à²šà²¿à²•****ಪà³à²°à²¯à³‹à²—.**
**ಅಧà³à²¯à²¯à²¨ ವಿಷಯ:** “**Determiningeffectiveness of paravertebral block on blood loss in percutaneous nephrolithotomy surgeries : arandomized controlled trial****â€**
```
ಡಾ ಪà³à²°à²¿à²¯à²¾à²‚ಕಾ ಡಿ ನಡೆಸà³à²¤à³à²¤à²¿à²°à³à²µ ಸಂಶೋಧನೆ ಕà³à²°à²¿à²¤à³ ನಾನೠವಿವರಣೆಯನà³à²¨à³ ಪಡೆದಿದà³à²¦à³‡à²¨à³† ಮತà³à²¤à³ ಈ ವಿವರಣೆಯನà³à²¨à³ ನನಗೆ ನನà³à²¨ ಮಾತೃ à²à²¾à²·à³†à²¯à²²à³à²²à³‡ ನೀಡಲಾಗಿದೆ. ಅದರ ಬಗà³à²—ೆ ಪà³à²°à²¶à³à²¨à³†à²—ಳನà³à²¨à³ ಕೇಳಲೠನನಗೆ ಅವಕಾಶವನà³à²¨à³ ನೀಡಲಾಗಿತà³à²¤à³ ಮತà³à²¤à³ ನಾನೠಕೇಳಿದ ಎಲà³à²²à²¾ ಪà³à²°à²¶à³à²¨à³†à²—ಳಿಗೆ ತೃಪà³à²¤à²¿à²•à²°à²µà²¾à²—ಿ ಉತà³à²¤à²°à²—ಳನà³à²¨à³ ನೀಡಲಾಗಿದೆ. ನಾನೠಈ ಸಂಶೋಧನೆಯಲà³à²²à²¿ ಸಹà²à²¾à²—ಿಯಾಗಿ ಪಾಲà³à²—ೊಳà³à²³à²²à³ ಸà³à²µà²‡à²šà³à²›à³†à²¯à²¿à²‚ದ ಸಮà³à²®à²¤à²¿à²¸à²¿à²¦à³à²¦à³‡à²¨à³† ಮತà³à²¤à³ ಯಾವà³à²¦à³‡ ರೀತಿ ನನಗೆ ವೈದà³à²¯à²•à³€à²¯à²µà²¾à²—ಿ ತೊಂದರೆಯಾದರೆ ಯಾವà³à²¦à³‡ ಸಂದರà³à²à²¦à²²à³à²²à²¿ ಸಂಶೋಧನೆಯಿಂದ ಹಿಂದೆ ಸರಿಯà³à²µ ಹಕà³à²•à²¨à³à²¨à³ ಹೊಂದಿದà³à²¦à³‡à²¨à³†à²¨à³à²¨à³à²µà³à²¦à²¨à³à²¨à³ ಬಲà³à²²à²µà²¨à²¾à²—ಿದà³à²¦à³‡à²¨à³†.
```
**à²à²¾à²—ವಹಿಸà³à²µà²µà²° ಹೆಸರೠ:...................................................................**
**à²à²¾à²—ವಹಿಸà³à²µà²µà²°à³****ಸಹಿ :...................................................................**
**ದಿನಾಂಕ: ( ದಿನ/ತಿಂಗಳà³/ವರà³à²·):............................................................**
**ಅನಕà³à²·à²°à²¸à³à²¥à²°à²¾à²—ಿದà³à²¦à²²à³à²²à²¿:** ಒಬà³à²¬ ಅಕà³à²·à²°à²¸à³à²¥ ಸಹಿ ಮಾಡà³à²µà³à²¦à³à²•à²¡à³à²¡à²¾à²¯. (ಸಾಧà³à²¯à²µà²¾à²¦à²²à³à²²à²¿ ಈ ವà³à²¯à²•à³à²¤à²¿à²¯à²¨à³à²¨à³à²¸à²‚ಶೋಧನೆಯಲà³à²²à²¿ à²à²¾à²—ವಹಿಸà³à²µà²µà²°à³
ಆಯà³à²•à³†à²®à²¾à²¡à²¬à³‡à²•à³ ಮತà³à²¤à³ ಸಂಶೋಧನಾ ತಂಡದ ಜೊತೆಈತ ಯಾವà³à²¦à³‡ ಸಂಪರà³à²• ಹೊಂದಿರಬಾರದà³).
ನಾನೠಸಮà³à²®à²¤à²¿ ನಮೂನೆಯನà³à²¨à³à²“ದಿದà³à²¦à³‡à²¨à³† ಮತà³à²¤à³ ನಿಖರವಾಗಿ ಓದಿರà³à²µà³à²¦à²¨à³à²¨à³ ಸಾಕà³à²·à³€à²•à²°à²¿à²¸à²¿à²¦à³à²¦à³‡à²¨à³†. ಸಂಶೋಧನೆಯ ಸಂà²à²¾à²µà³à²¯ ಅà²à³à²¯à²°à³à²¥à²¿à²—ೆಓದಿ ತಿಳಿಸಲಾಗಿದà³à²¦à³, ಅವರ ಸಂಶಯಗಳನà³à²¨à³ ಪರಿಹರಿಸಿಕೊಳà³à²³à²²à³, ಪà³à²°à²¶à³à²¨à³†à²—ಳನà³à²¨à³ ಕೇಳಲೠಅವಕಾಶ ನೀಡಲಾಗಿತà³à²¤à³.à²à²¾à²—ವಹಿಸà³à²µà²µà²°à³ ಮà³à²•à³à²¤à²µà²¾à²—ಿ ಒಪà³à²ªà²¿à²—ೆ ನೀಡಿರà³à²¤à³à²¤à²¾à²°à³†à²‚ಬà³à²¦à²¨à³à²¨à³ ನಾನೠದೃಢಪಡಿಸà³à²¤à³à²¤à³‡à²¨à³†.
**ಸಾಕà³à²·à²¿à²¯ ಹೆಸರà³......................................**
**ಸಾಕà³à²·à²¿à²¯ ಸಹಿ ......................................**
**ದಿನಾಂಕ : (ದಿನ/ತಿಂಗಳà³/ವರà³à²·):........................** **à²à²¾à²—ವಹಿಸà³à²µà²µà²°à²¹à³†à²¬à³à²¬à³†à²Ÿà³à²Ÿà²¿à²¨ ಗà³à²°à³à²¤à³**
ನಾನೠಇದನà³à²¨à³ ಓದಿದà³à²¦à³‡à²¨à³†à²®à²¤à³à²¤à³ à²à²¾à²—ವಹಿಸà³à²µà²µà²°à²¿à²—ೆ ಸಮà³à²®à²¤à²¿ ನಮೂನೆಯನà³à²¨à³ ನಿಖರವಾಗಿ ಓದಿರà³à²µà³à²¦à²¨à³à²¨à³ ಸಾಕà³à²·à³€à²•à²°à²¿à²¸à²¿à²¦à³à²¦à³‡à²¨à³†.à²à²¾à²—ವಹಿಸà³à²¤à³à²¤à²¿à²°à³à²µà²µà²°à³ ಪà³à²°à²¶à³à²¨à³†à²—ಳನà³à²¨à³ ಕೇಳಲೠಅವಕಾಶ ನೀಡಲಾಗಿದೆ. à²à²¾à²—ವಹಿಸà³à²µà²µà²°à³ ಸà³à²µ ಪà³à²°à³‡à²°à²£à³†à²¯à²¿à²‚ದಒಪà³à²ªà²¿à²—ೆ ನೀಡಿರà³à²µà³à²¦à²¨à³à²¨à³ ನಾನೠದೃಢಪಡಿಸà³à²¤à³à²¤à³‡à²¨à³†. ಈ ವಿಷಯದಲà³à²²à²¿ ಯಾವà³à²¦à³‡ ಅನà³à²®à²¾à²¨à²—ಳಿದà³à²¦à²²à³à²²à²¿ ನನà³à²¨à²¨à³à²¨à³à²¸à²‚ಪರà³à²•à²¿à²¸à³à²µà²‚ತೆ ಕೇಳಿಕೊಳà³à²³à²²à²¾à²—ಿದೆ.
```
DR RASHMI
```
```
ASSISTANT PROFESSOR ,DEPARTMENT OF ANESTHESIOLOGY
```
**ಸಂಶೋಧಕರ ಹೆಸರà³:.....................................**
**ಸಂಶೋಧಕರ ಸಹಿ :..........................................**
**ದಿನಾಂಕ : (ದಿನ/ತಿಂಗಳà³/ವರà³à²·):........................**
**PROFORMA**
**A)****PATIENTS PROFILE:**
**Name: Diagnosis:**
**Age: Surgery:**
**Sex: Date of surgery:**
**IP No:**
**B) GENERALPHYSICAL EXAMINATION:**
**Weight: Height:**
**BMI:**
**Pulse: BP: RR: Temperature:**
**Pallor: Icterus: Cyanosis: Clubbing: Lymphadenopathy:**
**SYSTEMIC EXAMINATION:**
**CVS:**
**RS:**
**PA:**
Time ofadministration of bock:
Patientshifted out to the ward after hours ofsurgery.
Time ofgiving rescue analgesia:
Total dose ofrescue analgesic in 24hr:
Complicationsif any:
| | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|0
1 hr
2 hr
4 hr
6 hr
12 hr
24 hr
|
|
|VITALS:
SBP
|DBP
|MAP
|HR
|RR
| SPO2
Hematocri t and haemoglobin preoperative;Hematocrit and haemoglobin 24 hr posto
**Title of the project****:** Effect of Paravertebral Block on reducing bloodloss in Percutaneous Nephrolithotomy (PCNL)surgeries : Randomized Controlled Trial.
Dr Rashmi, Assistant professor, Department of anesthesiology and criticalcare, RRMCH, Bangalore
Dr. Shankar K, Assistant professor, Department of anesthesiology and Criticalcare, RRMCH, Bangalore
**NEED FOR STUDY**
Percutaneous nephrolithotomy(PCNL) is a minimally invasive urologicalprocedure done as treatment for kidney stones greater than 20mm or incircumstances where kidney stones are not broken by extra corpororeal shockwave lithotripsy1. The extraction of stones is done percutaneouslythrough a small incision leading to lesser morbidity and shortens hospital stay2.
Bleeding is one of the majorcomplication associated with percutaneous nephro lithotomy. Pelvicalycealsystem is opened up and intrarenal manipulations can cause injury to the renalvasculature, especially the interlobar and segmental arteries3.
Creating multiple tracts, diabetes, prolonged duration of surgery areassociated with increased blood loss4.
Methods like use of tranexamic acid and Mini percutaneous nephrolithotomyvia small percutaneous tract (11- 20 F) have been used to reduce blood loss butthe results are inconclusive5,6.
Paravertebral block with local anesthetics causes sympathetic nerveblock with reduces the pressures in the regional vasculature, decreases neuroendocrine stress response and there by reducing the blood loss 7.
Hence we are conducting this study to see the effectof unilateral paravertebral block given beforesurgery to reduce intra operative blood loss.
**REVIEW OF LITERATURE:**
**Kukreja** et al in 2004 did a study to determine factorsaffecting blood loss during percutaneous nephrolithotomy .It was a prospectivestudy which concluded preoperative hemoglobin , multiple tracts , stone size,and total blood loss were significant in predicting blood transfusionrequirement. Factors such as age, hypertension, renal insufficiency , urinarytract infection, the degree of hydronephrosis, stone bulk and function ofipsilateral kidney did not have anyaffect on blood loss4.
**Said** et al in 2016reviewed factors affecting total blood loss and need for blood transfusion in aseries of patient undergoing unilateral percutaneous nephrolithostomy. Itshowed factors which affecting rate of blood transfusion were intraoperative complications like perforationand extravasation, stone complexity, operative time and preoperative creatininelevel8.
**Syahputra** et al in 2016 conducted a study on blood loss predictive factors and transfusionpractice during percutaneous nephrolithostomy of kidney stones. It was aprospective randomised study which determined stone burden as major predictorof blood loss3.
**Meng et al** in 2019 analysed the risk factors for heamorrhage associated withminimally invasive percutaneous nephrolithostomy. Retrospective analysis determinedthat surgeons experience, stone size, staghorn calculi, operation time wererisk factors for bleeding intraoperatively9.
**Mohammadi** et al in 2019 studied effect of tranexamic acid onbleeding and hemoglobin levels in patients with staghorn calculi undergoingpercutaneous nephrolithotomy. This randomised controlled trial concluded thattranexamic acid reduced risk of bleeding and attenuated the drop in thehemoglobin level5.
**AIM:** To assess the efficacy of USG guidedunilateral paravertebral block for reduction of blood loss in PCNL surgeries
**Objectives –**
• Comparison of hemodynamic parameters.
• To study the safety profile of abovetechniques and the drugs used.
**MATERIALSAND METHODS****:**
A) **Study design**: Randomized control trial
B)**Study period**:3 month
B) **Place ofstudy**: Inpatients at hospitals attached toRajarajeswari Medical College and hospital, Bangalore.
C) **Sample size**: Afterconducting a pilot study average drop in the hemoglobin in was 2.5g/dl and 0.83g/dl in control group andparavertebral group respectively. Considering effect size as 1.6, alpha erroras 0.05 and power of 80%, 23 patients per group was obtained. To avoid studyattrition and errors 25 patients per group was taken up for study.
**E) Inclusion Criteria:**
1. Adult patients between 18-60yr of age ofeither sex.
2. ASA status Iand II
3. Undergoingunilateral PCNL surgeries.
**F)Exclusion Criteria:**
1. Patientsrefusing to participate in the study
2. Patient withuncontrolled hypertension, diabetes, cardio-respiratory disorders,neuro-psychiatric disorders, hepatic or renal dysfunction.
3.Coagulopathy, infection at the site of block, neurological deficits.
4. Patients onmedications like opioids, sedatives, anti-psychotics, anti-epileptics.
5. Pregnant orlactating mothers.
6.Alcoholic
7.Allergic tostudy drug
**Methodology of Study:**
Following approval of institutional ethical committee50 patients will be taken up for the study after testing negetive for COVID 19.Pre anesthetic evaluation will be done for all the patients and preoperativehemoglobin will be noted. Written informed consent will be taken. All patientswill be kept nil per oral for 8hrs.
In operation theatre standardmonitors will be attached and baseline parameters will be recorded. Thepatients are randomized with help of sealed opaque envelope technique into twogroups. Group C is taken as control group and Group P will receive ultrasoundguided unilateral paravertebral block.
In group P, paravertebral block will be performed in sitting position underultrasound guidance with 22G echogenic needle after identifying the landmarksat the T10-T11 levelsusing 20 ml of 0.375% ropivacaine. Thespread of the local anaesthetic will be confirmed by anterior movement of thepleura in the paravertebral space.
In the control group, no intervention was performed.All blocks will be performed by the same experienced anesthesiologist.
Patient will be placed in supine position andpremedicated with Injection midazolam 0.02mg/kg, glycopyrrolate 0.005mg/kg, andfentanyl 1-2mcg/kg 5min before induction. After pre oxygenation with 100% O2for 3-5min, patient will be induced with injection of propofol 2-2.5mg/kg tillthe loss of verbal commands. Neuromuscular blockade to facilitate placement ofendotracheal tube will be achieved by injection vecurronium 0.08-0.1mg/kg. Anaesthesia will be maintained with oxygen,nitrous oxide, isoflurane, and vecuronium. After the insertion of a urinary catheter, the patientswill be placed in the prone position for the surgery. Hemodynamicswill be monitored throughout the surgery. The patient will be placed back insupine position after completion of surgery, extubated after meeting theexubation criteria and shifted to post anesthesia care unit for monitoring.
Repeat hemoglobin will be performed 24 hours aftersurgery.
**STATISTICAL ANALYSIS**
Samplesize estimation: After conducting a pilot study average drop in thehemoglobin in was 2.5g/dl and 0.83g/dl in control group and paravertebral grouprespectively. Considering effect size as 1.6, alpha error as 0.05 and power of80%, 23 patients per group was obtained. To avoid study attrition and errors 25patients per group was taken up for study.
Statisticalanalysis will be done using SSPS software 16 version as follows:
Student T test will beused to compare nominal data between the groups.
Chi square test will beused to compare categorical data between the groups.
P value <0.05 willbe considered significantly.
**DOESTHE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED ONPATIENTS OR OTHERS HUMANS OR ANIMALS? IF SO, PLEASE DESCRIBE BRIEFLY**
The study doesn’trequire any intervention on animals.
Routineinvestigations relevant for surgery - Complete blood count, RBS, RFT, serumelectrolytes, ECG, chest X ray.
**LISTOF REFERENCES:**
1. Gupta M, Ost MS, Shah JB, et al. Percutaneousmanagement of upper urinary tract. In Wein AJ, et al (eds). Campbell WalshUrology, 9th ed. Philadelphia, Saunders Elsevier, 2007.
2.Carrion D, Cancino J R,Quintana L M, et al: Prone percutaneous nephro lithotomy: its advantage and ourtechnique for puncture. Transl Androl Urol. 2018 Dec; 7(6):950-959
3. Syahputra FA, Birowo P,Rasyid N, Matondang FA, Noviandrini E, Huseini MH. Blood loss predictivefactors and transfusion practice during percutaneous nephrolithotomy of kidneystones: a prospective study. *F1000Res*. 2016;5:1550. Published 2016 Jun30. doi:10.12688/f1000research.8993.
4. Kukreja R, Desai M, Patel S, Bapat S, Desai M. Factorsaffecting blood loss during percutaneous nephrolithotomy: Prospective study. J Endourol. 2004;18:715–722. doi:10.1089/0892779042360599.
5. Mohammadi Sichani M, KazemiR, Nouri-Mahdavi K, Gholipour F. **Re-evaluationof the efficacy of tranexamic acid in reducing blood loss in percutaneousnephrolithotomy: a randomized clinical trial.**Minerva Urol Nefrol. 2019;71(1):. <https://doi.org/10.23736/S0393-2249.18.03151-X>
6. Ferakis N, Stavropoulos M.Mini percutaneous nephrolithotomy in the treatment of renal and upper ureteralstones: Lessons learned from review of the literature. Urol Ann. 2015 Apr-Jun;7(2): 141-148
7. Batra RK, Krishnan K,Agarwal A. Paravertebral block. J Anaesthesiol Clin Pharmacol.2011 Jan-Mar;27(1):5-11.
8. Said S, Aghaways I, FryadG. Review of factors affecting total blood loss and need for blood transfusionin a series of patient undergoing unilateral percutaneous nephrolithotomy. UrolNephrol Open Access J. 2016;3(6):208-213
9. Meng X, Bao J, Mi Q et al:The analysis of risk factors for heamorrhage associated with minimally invasivepercutaneous nephrolithostomy.
| |
| --- |
|BioMed Research International. 2019;2019:1. <https://doi.org/10.1155/2019/8619460>
**CERTIFICATE**
Thedissertation topic “**Effect of paravertebral block on reducing bloodloss in percutaneous nephrolithotomy(PCNL) surgeries : Randomized controlledtrial****â€**
AtRajarajeshwari Medical College and Hospital, Bangalore by Dr. Priyanka D ,post-graduate student in the Department of Anesthesiology has been approved bythe institutional ethical committee, RAJARAJESWARI MEDICAL COLLEGE, BANGALORE.
**INFORMED CONSENT**
I, Dr. Rashmi, Assistant professor, Department of anaesthesiaconducting a randomized trial for award of MD degree in Anaesthesia. The topic of thestudy is: “**Determining effectiveness ofparavertebral block on blood loss inpercutaneous nephrolithotomy surgeries : a randomized controlled trial****â€**
I have been briefedon the foregoing research being conducted by Dr. Rashmi and it has beenconveyed to me in my own language .I have had the opportunity to ask questionsabout it & all questions that I have asked have been answered to mysatisfaction. I consent voluntarily to participate as a participant in thisresearch & understand that I have the right to withdraw from the researchat any time without in any way affecting my medical care.
Name of theparticipant:.......................................................................................... Signature of theparticipant: ..........................................................................................Date:(d/m/y).......................................................................................
If illiterate: A literate witnessmust sign ( If possible this person should be selected by the
participant andshould have no connection to the research team)I have read and witnessed theaccurate reading of the consent form to the potential participant and theindividual has had the opportunity to ask questions, I confirm that theindividual has given consent freely.
Name of thewitness................................................... Signature ofwitness.............................................. Date:(d/m/y)....................................................
Thumb impression ofparticipant
I have read andwitnessed the accurate reading of the consent form to the potential participantand the individual has had the opportunity to ask questions, I confirm that theindividual has given consent freely. In case of any doubt I have been asked tocontact: Dr. Rashmi, assistant professor indepartment of anaesthesiology
Name ofResearcher:...............................................................Signature of researcher:............................................................
Date :(d/m/y)........................................................................
**ತಿಳಿವಳಿಕೆಯà³à²³à³à²³ ಸಮà³à²®à²¤à²¿à²¨à²®à³‚ನೆ.**
**ನಾನà³, ಅರಿವಳಿಕೆ ಸà³à²¨à²¾à²¤à²•à³‹à²¤à³à²¤à²°à²µà²¿à²à²¾à²—ದ** ಡಾ RASHMI **ಅರಿವಳಿಕೆ ವಿಷಯದಲà³à²²à²¿à²¨** **‘****ಡಾಕà³à²Ÿà²°à³ ಆಫೠಮೆಡಿಸನà³****‌****‘****(ಎಂಡಿ) ಪದವಿಗಾಗಿ ನಡೆಸà³à²¤à³à²¤à²¿à²°à³à²µ****ಯಾದೃಚà³à²šà²¿à²•****ಪà³à²°à²¯à³‹à²—.**
**ಅಧà³à²¯à²¯à²¨ ವಿಷಯ:** “**Determiningeffectiveness of paravertebral block on blood loss in percutaneous nephrolithotomy surgeries : arandomized controlled trial****â€**
```
ಡಾ ಪà³à²°à²¿à²¯à²¾à²‚ಕಾ ಡಿ ನಡೆಸà³à²¤à³à²¤à²¿à²°à³à²µ ಸಂಶೋಧನೆ ಕà³à²°à²¿à²¤à³ ನಾನೠವಿವರಣೆಯನà³à²¨à³ ಪಡೆದಿದà³à²¦à³‡à²¨à³† ಮತà³à²¤à³ ಈ ವಿವರಣೆಯನà³à²¨à³ ನನಗೆ ನನà³à²¨ ಮಾತೃ à²à²¾à²·à³†à²¯à²²à³à²²à³‡ ನೀಡಲಾಗಿದೆ. ಅದರ ಬಗà³à²—ೆ ಪà³à²°à²¶à³à²¨à³†à²—ಳನà³à²¨à³ ಕೇಳಲೠನನಗೆ ಅವಕಾಶವನà³à²¨à³ ನೀಡಲಾಗಿತà³à²¤à³ ಮತà³à²¤à³ ನಾನೠಕೇಳಿದ ಎಲà³à²²à²¾ ಪà³à²°à²¶à³à²¨à³†à²—ಳಿಗೆ ತೃಪà³à²¤à²¿à²•à²°à²µà²¾à²—ಿ ಉತà³à²¤à²°à²—ಳನà³à²¨à³ ನೀಡಲಾಗಿದೆ. ನಾನೠಈ ಸಂಶೋಧನೆಯಲà³à²²à²¿ ಸಹà²à²¾à²—ಿಯಾಗಿ ಪಾಲà³à²—ೊಳà³à²³à²²à³ ಸà³à²µà²‡à²šà³à²›à³†à²¯à²¿à²‚ದ ಸಮà³à²®à²¤à²¿à²¸à²¿à²¦à³à²¦à³‡à²¨à³† ಮತà³à²¤à³ ಯಾವà³à²¦à³‡ ರೀತಿ ನನಗೆ ವೈದà³à²¯à²•à³€à²¯à²µà²¾à²—ಿ ತೊಂದರೆಯಾದರೆ ಯಾವà³à²¦à³‡ ಸಂದರà³à²à²¦à²²à³à²²à²¿ ಸಂಶೋಧನೆಯಿಂದ ಹಿಂದೆ ಸರಿಯà³à²µ ಹಕà³à²•à²¨à³à²¨à³ ಹೊಂದಿದà³à²¦à³‡à²¨à³†à²¨à³à²¨à³à²µà³à²¦à²¨à³à²¨à³ ಬಲà³à²²à²µà²¨à²¾à²—ಿದà³à²¦à³‡à²¨à³†.
```
**à²à²¾à²—ವಹಿಸà³à²µà²µà²° ಹೆಸರೠ:...................................................................**
**à²à²¾à²—ವಹಿಸà³à²µà²µà²°à³****ಸಹಿ :...................................................................**
**ದಿನಾಂಕ: ( ದಿನ/ತಿಂಗಳà³/ವರà³à²·):............................................................**
**ಅನಕà³à²·à²°à²¸à³à²¥à²°à²¾à²—ಿದà³à²¦à²²à³à²²à²¿:** ಒಬà³à²¬ ಅಕà³à²·à²°à²¸à³à²¥ ಸಹಿ ಮಾಡà³à²µà³à²¦à³à²•à²¡à³à²¡à²¾à²¯. (ಸಾಧà³à²¯à²µà²¾à²¦à²²à³à²²à²¿ ಈ ವà³à²¯à²•à³à²¤à²¿à²¯à²¨à³à²¨à³à²¸à²‚ಶೋಧನೆಯಲà³à²²à²¿ à²à²¾à²—ವಹಿಸà³à²µà²µà²°à³
ಆಯà³à²•à³†à²®à²¾à²¡à²¬à³‡à²•à³ ಮತà³à²¤à³ ಸಂಶೋಧನಾ ತಂಡದ ಜೊತೆಈತ ಯಾವà³à²¦à³‡ ಸಂಪರà³à²• ಹೊಂದಿರಬಾರದà³).
ನಾನೠಸಮà³à²®à²¤à²¿ ನಮೂನೆಯನà³à²¨à³à²“ದಿದà³à²¦à³‡à²¨à³† ಮತà³à²¤à³ ನಿಖರವಾಗಿ ಓದಿರà³à²µà³à²¦à²¨à³à²¨à³ ಸಾಕà³à²·à³€à²•à²°à²¿à²¸à²¿à²¦à³à²¦à³‡à²¨à³†. ಸಂಶೋಧನೆಯ ಸಂà²à²¾à²µà³à²¯ ಅà²à³à²¯à²°à³à²¥à²¿à²—ೆಓದಿ ತಿಳಿಸಲಾಗಿದà³à²¦à³, ಅವರ ಸಂಶಯಗಳನà³à²¨à³ ಪರಿಹರಿಸಿಕೊಳà³à²³à²²à³, ಪà³à²°à²¶à³à²¨à³†à²—ಳನà³à²¨à³ ಕೇಳಲೠಅವಕಾಶ ನೀಡಲಾಗಿತà³à²¤à³.à²à²¾à²—ವಹಿಸà³à²µà²µà²°à³ ಮà³à²•à³à²¤à²µà²¾à²—ಿ ಒಪà³à²ªà²¿à²—ೆ ನೀಡಿರà³à²¤à³à²¤à²¾à²°à³†à²‚ಬà³à²¦à²¨à³à²¨à³ ನಾನೠದೃಢಪಡಿಸà³à²¤à³à²¤à³‡à²¨à³†.
**ಸಾಕà³à²·à²¿à²¯ ಹೆಸರà³......................................**
**ಸಾಕà³à²·à²¿à²¯ ಸಹಿ ......................................**
**ದಿನಾಂಕ : (ದಿನ/ತಿಂಗಳà³/ವರà³à²·):........................** **à²à²¾à²—ವಹಿಸà³à²µà²µà²°à²¹à³†à²¬à³à²¬à³†à²Ÿà³à²Ÿà²¿à²¨ ಗà³à²°à³à²¤à³**
ನಾನೠಇದನà³à²¨à³ ಓದಿದà³à²¦à³‡à²¨à³†à²®à²¤à³à²¤à³ à²à²¾à²—ವಹಿಸà³à²µà²µà²°à²¿à²—ೆ ಸಮà³à²®à²¤à²¿ ನಮೂನೆಯನà³à²¨à³ ನಿಖರವಾಗಿ ಓದಿರà³à²µà³à²¦à²¨à³à²¨à³ ಸಾಕà³à²·à³€à²•à²°à²¿à²¸à²¿à²¦à³à²¦à³‡à²¨à³†.à²à²¾à²—ವಹಿಸà³à²¤à³à²¤à²¿à²°à³à²µà²µà²°à³ ಪà³à²°à²¶à³à²¨à³†à²—ಳನà³à²¨à³ ಕೇಳಲೠಅವಕಾಶ ನೀಡಲಾಗಿದೆ. à²à²¾à²—ವಹಿಸà³à²µà²µà²°à³ ಸà³à²µ ಪà³à²°à³‡à²°à²£à³†à²¯à²¿à²‚ದಒಪà³à²ªà²¿à²—ೆ ನೀಡಿರà³à²µà³à²¦à²¨à³à²¨à³ ನಾನೠದೃಢಪಡಿಸà³à²¤à³à²¤à³‡à²¨à³†. ಈ ವಿಷಯದಲà³à²²à²¿ ಯಾವà³à²¦à³‡ ಅನà³à²®à²¾à²¨à²—ಳಿದà³à²¦à²²à³à²²à²¿ ನನà³à²¨à²¨à³à²¨à³à²¸à²‚ಪರà³à²•à²¿à²¸à³à²µà²‚ತೆ ಕೇಳಿಕೊಳà³à²³à²²à²¾à²—ಿದೆ.
```
DR RASHMI
```
```
ASSISTANT PROFESSOR ,DEPARTMENT OF ANESTHESIOLOGY
```
**ಸಂಶೋಧಕರ ಹೆಸರà³:.....................................**
**ಸಂಶೋಧಕರ ಸಹಿ :..........................................**
**ದಿನಾಂಕ : (ದಿನ/ತಿಂಗಳà³/ವರà³à²·):........................**
**PROFORMA**
**A)****PATIENTS PROFILE:**
**Name: Diagnosis:**
**Age: Surgery:**
**Sex: Date of surgery:**
**IP No:**
**B) GENERALPHYSICAL EXAMINATION:**
**Weight: Height:**
**BMI:**
**Pulse: BP: RR: Temperature:**
**Pallor: Icterus: Cyanosis: Clubbing: Lymphadenopathy:**
**SYSTEMIC EXAMINATION:**
**CVS:**
**RS:**
**PA:**
Time ofadministration of bock:
Patientshifted out to the ward after hours ofsurgery.
Time ofgiving rescue analgesia:
Total dose ofrescue analgesic in 24hr:
Complicationsif any:
| | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|0
1 hr
2 hr
4 hr
6 hr
12 hr
24 hr
|
|
|VITALS:
SBP
|DBP
|MAP
|HR
|RR
| SPO2
Hematocri t and haemoglobin preoperative;Hematocrit and haemoglobin 24 hr posto
**Title of the project****:** Effect of Paravertebral Block on reducing bloodloss in Percutaneous Nephrolithotomy (PCNL)surgeries : Randomized Controlled Trial.
Dr Rashmi, Assistant professor, Department of anesthesiology and criticalcare, RRMCH, Bangalore
Dr. Shankar K, Assistant professor, Department of anesthesiology and Criticalcare, RRMCH, Bangalore
**NEED FOR STUDY**
Percutaneous nephrolithotomy(PCNL) is a minimally invasive urologicalprocedure done as treatment for kidney stones greater than 20mm or incircumstances where kidney stones are not broken by extra corpororeal shockwave lithotripsy1. The extraction of stones is done percutaneouslythrough a small incision leading to lesser morbidity and shortens hospital stay2.
Bleeding is one of the majorcomplication associated with percutaneous nephro lithotomy. Pelvicalycealsystem is opened up and intrarenal manipulations can cause injury to the renalvasculature, especially the interlobar and segmental arteries3.
Creating multiple tracts, diabetes, prolonged duration of surgery areassociated with increased blood loss4.
Methods like use of tranexamic acid and Mini percutaneous nephrolithotomyvia small percutaneous tract (11- 20 F) have been used to reduce blood loss butthe results are inconclusive5,6.
Paravertebral block with local anesthetics causes sympathetic nerveblock with reduces the pressures in the regional vasculature, decreases neuroendocrine stress response and there by reducing the blood loss 7.
Hence we are conducting this study to see the effectof unilateral paravertebral block given beforesurgery to reduce intra operative blood loss.
**REVIEW OF LITERATURE:**
**Kukreja** et al in 2004 did a study to determine factorsaffecting blood loss during percutaneous nephrolithotomy .It was a prospectivestudy which concluded preoperative hemoglobin , multiple tracts , stone size,and total blood loss were significant in predicting blood transfusionrequirement. Factors such as age, hypertension, renal insufficiency , urinarytract infection, the degree of hydronephrosis, stone bulk and function ofipsilateral kidney did not have anyaffect on blood loss4.
**Said** et al in 2016reviewed factors affecting total blood loss and need for blood transfusion in aseries of patient undergoing unilateral percutaneous nephrolithostomy. Itshowed factors which affecting rate of blood transfusion were intraoperative complications like perforationand extravasation, stone complexity, operative time and preoperative creatininelevel8.
**Syahputra** et al in 2016 conducted a study on blood loss predictive factors and transfusionpractice during percutaneous nephrolithostomy of kidney stones. It was aprospective randomised study which determined stone burden as major predictorof blood loss3.
**Meng et al** in 2019 analysed the risk factors for heamorrhage associated withminimally invasive percutaneous nephrolithostomy. Retrospective analysis determinedthat surgeons experience, stone size, staghorn calculi, operation time wererisk factors for bleeding intraoperatively9.
**Mohammadi** et al in 2019 studied effect of tranexamic acid onbleeding and hemoglobin levels in patients with staghorn calculi undergoingpercutaneous nephrolithotomy. This randomised controlled trial concluded thattranexamic acid reduced risk of bleeding and attenuated the drop in thehemoglobin level5.
**AIM:** To assess the efficacy of USG guidedunilateral paravertebral block for reduction of blood loss in PCNL surgeries
**Objectives –**
• Comparison of hemodynamic parameters.
• To study the safety profile of abovetechniques and the drugs used.
**MATERIALSAND METHODS****:**
A) **Study design**: Randomized control trial
B)**Study period**:3 month
B) **Place ofstudy**: Inpatients at hospitals attached toRajarajeswari Medical College and hospital, Bangalore.
C) **Sample size**: Afterconducting a pilot study average drop in the hemoglobin in was 2.5g/dl and 0.83g/dl in control group andparavertebral group respectively. Considering effect size as 1.6, alpha erroras 0.05 and power of 80%, 23 patients per group was obtained. To avoid studyattrition and errors 25 patients per group was taken up for study.
**E) Inclusion Criteria:**
1. Adult patients between 18-60yr of age ofeither sex.
2. ASA status Iand II
3. Undergoingunilateral PCNL surgeries.
**F)Exclusion Criteria:**
1. Patientsrefusing to participate in the study
2. Patient withuncontrolled hypertension, diabetes, cardio-respiratory disorders,neuro-psychiatric disorders, hepatic or renal dysfunction.
3.Coagulopathy, infection at the site of block, neurological deficits.
4. Patients onmedications like opioids, sedatives, anti-psychotics, anti-epileptics.
5. Pregnant orlactating mothers.
6.Alcoholic
7.Allergic tostudy drug
**Methodology of Study:**
Following approval of institutional ethical committee50 patients will be taken up for the study after testing negetive for COVID 19.Pre anesthetic evaluation will be done for all the patients and preoperativehemoglobin will be noted. Written informed consent will be taken. All patientswill be kept nil per oral for 8hrs.
In operation theatre standardmonitors will be attached and baseline parameters will be recorded. Thepatients are randomized with help of sealed opaque envelope technique into twogroups. Group C is taken as control group and Group P will receive ultrasoundguided unilateral paravertebral block.
In group P, paravertebral block will be performed in sitting position underultrasound guidance with 22G echogenic needle after identifying the landmarksat the T10-T11 levelsusing 20 ml of 0.375% ropivacaine. Thespread of the local anaesthetic will be confirmed by anterior movement of thepleura in the paravertebral space.
In the control group, no intervention was performed.All blocks will be performed by the same experienced anesthesiologist.
Patient will be placed in supine position andpremedicated with Injection midazolam 0.02mg/kg, glycopyrrolate 0.005mg/kg, andfentanyl 1-2mcg/kg 5min before induction. After pre oxygenation with 100% O2for 3-5min, patient will be induced with injection of propofol 2-2.5mg/kg tillthe loss of verbal commands. Neuromuscular blockade to facilitate placement ofendotracheal tube will be achieved by injection vecurronium 0.08-0.1mg/kg. Anaesthesia will be maintained with oxygen,nitrous oxide, isoflurane, and vecuronium. After the insertion of a urinary catheter, the patientswill be placed in the prone position for the surgery. Hemodynamicswill be monitored throughout the surgery. The patient will be placed back insupine position after completion of surgery, extubated after meeting theexubation criteria and shifted to post anesthesia care unit for monitoring.
Repeat hemoglobin will be performed 24 hours aftersurgery.
**STATISTICAL ANALYSIS**
Samplesize estimation: After conducting a pilot study average drop in thehemoglobin in was 2.5g/dl and 0.83g/dl in control group and paravertebral grouprespectively. Considering effect size as 1.6, alpha error as 0.05 and power of80%, 23 patients per group was obtained. To avoid study attrition and errors 25patients per group was taken up for study.
Statisticalanalysis will be done using SSPS software 16 version as follows:
Student T test will beused to compare nominal data between the groups.
Chi square test will beused to compare categorical data between the groups.
P value <0.05 willbe considered significantly.
**DOESTHE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED ONPATIENTS OR OTHERS HUMANS OR ANIMALS? IF SO, PLEASE DESCRIBE BRIEFLY**
The study doesn’trequire any intervention on animals.
Routineinvestigations relevant for surgery - Complete blood count, RBS, RFT, serumelectrolytes, ECG, chest X ray.
**LISTOF REFERENCES:**
1. Gupta M, Ost MS, Shah JB, et al. Percutaneousmanagement of upper urinary tract. In Wein AJ, et al (eds). Campbell WalshUrology, 9th ed. Philadelphia, Saunders Elsevier, 2007.
2.Carrion D, Cancino J R,Quintana L M, et al: Prone percutaneous nephro lithotomy: its advantage and ourtechnique for puncture. Transl Androl Urol. 2018 Dec; 7(6):950-959
3. Syahputra FA, Birowo P,Rasyid N, Matondang FA, Noviandrini E, Huseini MH. Blood loss predictivefactors and transfusion practice during percutaneous nephrolithotomy of kidneystones: a prospective study. *F1000Res*. 2016;5:1550. Published 2016 Jun30. doi:10.12688/f1000research.8993.
4. Kukreja R, Desai M, Patel S, Bapat S, Desai M. Factorsaffecting blood loss during percutaneous nephrolithotomy: Prospective study. J Endourol. 2004;18:715–722. doi:10.1089/0892779042360599.
5. Mohammadi Sichani M, KazemiR, Nouri-Mahdavi K, Gholipour F. **Re-evaluationof the efficacy of tranexamic acid in reducing blood loss in percutaneousnephrolithotomy: a randomized clinical trial.**Minerva Urol Nefrol. 2019;71(1):. <https://doi.org/10.23736/S0393-2249.18.03151-X>
6. Ferakis N, Stavropoulos M.Mini percutaneous nephrolithotomy in the treatment of renal and upper ureteralstones: Lessons learned from review of the literature. Urol Ann. 2015 Apr-Jun;7(2): 141-148
7. Batra RK, Krishnan K,Agarwal A. Paravertebral block. J Anaesthesiol Clin Pharmacol.2011 Jan-Mar;27(1):5-11.
8. Said S, Aghaways I, FryadG. Review of factors affecting total blood loss and need for blood transfusionin a series of patient undergoing unilateral percutaneous nephrolithotomy. UrolNephrol Open Access J. 2016;3(6):208-213
9. Meng X, Bao J, Mi Q et al:The analysis of risk factors for heamorrhage associated with minimally invasivepercutaneous nephrolithostomy.
| |
| --- |
|BioMed Research International. 2019;2019:1. <https://doi.org/10.1155/2019/8619460>
**CERTIFICATE**
Thedissertation topic “**Effect of paravertebral block on reducing bloodloss in percutaneous nephrolithotomy(PCNL) surgeries : Randomized controlledtrial****â€**
AtRajarajeshwari Medical College and Hospital, Bangalore by Dr. Priyanka D ,post-graduate student in the Department of Anesthesiology has been approved bythe institutional ethical committee, RAJARAJESWARI MEDICAL COLLEGE, BANGALORE.
**INFORMED CONSENT**
I, Dr. Rashmi, Assistant professor, Department of anaesthesiaconducting a randomized trial for award of MD degree in Anaesthesia. The topic of thestudy is: “**Determining effectiveness ofparavertebral block on blood loss inpercutaneous nephrolithotomy surgeries : a randomized controlled trial****â€**
I have been briefedon the foregoing research being conducted by Dr. Rashmi and it has beenconveyed to me in my own language .I have had the opportunity to ask questionsabout it & all questions that I have asked have been answered to mysatisfaction. I consent voluntarily to participate as a participant in thisresearch & understand that I have the right to withdraw from the researchat any time without in any way affecting my medical care.
Name of theparticipant:.......................................................................................... Signature of theparticipant: ..........................................................................................Date:(d/m/y).......................................................................................
If illiterate: A literate witnessmust sign ( If possible this person should be selected by the
participant andshould have no connection to the research team)I have read and witnessed theaccurate reading of the consent form to the potential participant and theindividual has had the opportunity to ask questions, I confirm that theindividual has given consent freely.
Name of thewitness................................................... Signature ofwitness.............................................. Date:(d/m/y)....................................................
Thumb impression ofparticipant
I have read andwitnessed the accurate reading of the consent form to the potential participantand the individual has had the opportunity to ask questions, I confirm that theindividual has given consent freely. In case of any doubt I have been asked tocontact: Dr. Rashmi, assistant professor indepartment of anaesthesiology
Name ofResearcher:...............................................................Signature of researcher:............................................................
Date :(d/m/y)........................................................................
**ತಿಳಿವಳಿಕೆಯà³à²³à³à²³ ಸಮà³à²®à²¤à²¿à²¨à²®à³‚ನೆ.**
**ನಾನà³, ಅರಿವಳಿಕೆ ಸà³à²¨à²¾à²¤à²•à³‹à²¤à³à²¤à²°à²µà²¿à²à²¾à²—ದ** ಡಾ RASHMI **ಅರಿವಳಿಕೆ ವಿಷಯದಲà³à²²à²¿à²¨** **‘****ಡಾಕà³à²Ÿà²°à³ ಆಫೠಮೆಡಿಸನà³****‌****‘****(ಎಂಡಿ) ಪದವಿಗಾಗಿ ನಡೆಸà³à²¤à³à²¤à²¿à²°à³à²µ****ಯಾದೃಚà³à²šà²¿à²•****ಪà³à²°à²¯à³‹à²—.**
**ಅಧà³à²¯à²¯à²¨ ವಿಷಯ:** “**Determiningeffectiveness of paravertebral block on blood loss in percutaneous nephrolithotomy surgeries : arandomized controlled trial****â€**
```
ಡಾ ಪà³à²°à²¿à²¯à²¾à²‚ಕಾ ಡಿ ನಡೆಸà³à²¤à³à²¤à²¿à²°à³à²µ ಸಂಶೋಧನೆ ಕà³à²°à²¿à²¤à³ ನಾನೠವಿವರಣೆಯನà³à²¨à³ ಪಡೆದಿದà³à²¦à³‡à²¨à³† ಮತà³à²¤à³ ಈ ವಿವರಣೆಯನà³à²¨à³ ನನಗೆ ನನà³à²¨ ಮಾತೃ à²à²¾à²·à³†à²¯à²²à³à²²à³‡ ನೀಡಲಾಗಿದೆ. ಅದರ ಬಗà³à²—ೆ ಪà³à²°à²¶à³à²¨à³†à²—ಳನà³à²¨à³ ಕೇಳಲೠನನಗೆ ಅವಕಾಶವನà³à²¨à³ ನೀಡಲಾಗಿತà³à²¤à³ ಮತà³à²¤à³ ನಾನೠಕೇಳಿದ ಎಲà³à²²à²¾ ಪà³à²°à²¶à³à²¨à³†à²—ಳಿಗೆ ತೃಪà³à²¤à²¿à²•à²°à²µà²¾à²—ಿ ಉತà³à²¤à²°à²—ಳನà³à²¨à³ ನೀಡಲಾಗಿದೆ. ನಾನೠಈ ಸಂಶೋಧನೆಯಲà³à²²à²¿ ಸಹà²à²¾à²—ಿಯಾಗಿ ಪಾಲà³à²—ೊಳà³à²³à²²à³ ಸà³à²µà²‡à²šà³à²›à³†à²¯à²¿à²‚ದ ಸಮà³à²®à²¤à²¿à²¸à²¿à²¦à³à²¦à³‡à²¨à³† ಮತà³à²¤à³ ಯಾವà³à²¦à³‡ ರೀತಿ ನನಗೆ ವೈದà³à²¯à²•à³€à²¯à²µà²¾à²—ಿ ತೊಂದರೆಯಾದರೆ ಯಾವà³à²¦à³‡ ಸಂದರà³à²à²¦à²²à³à²²à²¿ ಸಂಶೋಧನೆಯಿಂದ ಹಿಂದೆ ಸರಿಯà³à²µ ಹಕà³à²•à²¨à³à²¨à³ ಹೊಂದಿದà³à²¦à³‡à²¨à³†à²¨à³à²¨à³à²µà³à²¦à²¨à³à²¨à³ ಬಲà³à²²à²µà²¨à²¾à²—ಿದà³à²¦à³‡à²¨à³†.
```
**à²à²¾à²—ವಹಿಸà³à²µà²µà²° ಹೆಸರೠ:...................................................................**
**à²à²¾à²—ವಹಿಸà³à²µà²µà²°à³****ಸಹಿ :...................................................................**
**ದಿನಾಂಕ: ( ದಿನ/ತಿಂಗಳà³/ವರà³à²·):............................................................**
**ಅನಕà³à²·à²°à²¸à³à²¥à²°à²¾à²—ಿದà³à²¦à²²à³à²²à²¿:** ಒಬà³à²¬ ಅಕà³à²·à²°à²¸à³à²¥ ಸಹಿ ಮಾಡà³à²µà³à²¦à³à²•à²¡à³à²¡à²¾à²¯. (ಸಾಧà³à²¯à²µà²¾à²¦à²²à³à²²à²¿ ಈ ವà³à²¯à²•à³à²¤à²¿à²¯à²¨à³à²¨à³à²¸à²‚ಶೋಧನೆಯಲà³à²²à²¿ à²à²¾à²—ವಹಿಸà³à²µà²µà²°à³
ಆಯà³à²•à³†à²®à²¾à²¡à²¬à³‡à²•à³ ಮತà³à²¤à³ ಸಂಶೋಧನಾ ತಂಡದ ಜೊತೆಈತ ಯಾವà³à²¦à³‡ ಸಂಪರà³à²• ಹೊಂದಿರಬಾರದà³).
ನಾನೠಸಮà³à²®à²¤à²¿ ನಮೂನೆಯನà³à²¨à³à²“ದಿದà³à²¦à³‡à²¨à³† ಮತà³à²¤à³ ನಿಖರವಾಗಿ ಓದಿರà³à²µà³à²¦à²¨à³à²¨à³ ಸಾಕà³à²·à³€à²•à²°à²¿à²¸à²¿à²¦à³à²¦à³‡à²¨à³†. ಸಂಶೋಧನೆಯ ಸಂà²à²¾à²µà³à²¯ ಅà²à³à²¯à²°à³à²¥à²¿à²—ೆಓದಿ ತಿಳಿಸಲಾಗಿದà³à²¦à³, ಅವರ ಸಂಶಯಗಳನà³à²¨à³ ಪರಿಹರಿಸಿಕೊಳà³à²³à²²à³, ಪà³à²°à²¶à³à²¨à³†à²—ಳನà³à²¨à³ ಕೇಳಲೠಅವಕಾಶ ನೀಡಲಾಗಿತà³à²¤à³.à²à²¾à²—ವಹಿಸà³à²µà²µà²°à³ ಮà³à²•à³à²¤à²µà²¾à²—ಿ ಒಪà³à²ªà²¿à²—ೆ ನೀಡಿರà³à²¤à³à²¤à²¾à²°à³†à²‚ಬà³à²¦à²¨à³à²¨à³ ನಾನೠದೃಢಪಡಿಸà³à²¤à³à²¤à³‡à²¨à³†.
**ಸಾಕà³à²·à²¿à²¯ ಹೆಸರà³......................................**
**ಸಾಕà³à²·à²¿à²¯ ಸಹಿ ......................................**
**ದಿನಾಂಕ : (ದಿನ/ತಿಂಗಳà³/ವರà³à²·):........................** **à²à²¾à²—ವಹಿಸà³à²µà²µà²°à²¹à³†à²¬à³à²¬à³†à²Ÿà³à²Ÿà²¿à²¨ ಗà³à²°à³à²¤à³**
ನಾನೠಇದನà³à²¨à³ ಓದಿದà³à²¦à³‡à²¨à³†à²®à²¤à³à²¤à³ à²à²¾à²—ವಹಿಸà³à²µà²µà²°à²¿à²—ೆ ಸಮà³à²®à²¤à²¿ ನಮೂನೆಯನà³à²¨à³ ನಿಖರವಾಗಿ ಓದಿರà³à²µà³à²¦à²¨à³à²¨à³ ಸಾಕà³à²·à³€à²•à²°à²¿à²¸à²¿à²¦à³à²¦à³‡à²¨à³†.à²à²¾à²—ವಹಿಸà³à²¤à³à²¤à²¿à²°à³à²µà²µà²°à³ ಪà³à²°à²¶à³à²¨à³†à²—ಳನà³à²¨à³ ಕೇಳಲೠಅವಕಾಶ ನೀಡಲಾಗಿದೆ. à²à²¾à²—ವಹಿಸà³à²µà²µà²°à³ ಸà³à²µ ಪà³à²°à³‡à²°à²£à³†à²¯à²¿à²‚ದಒಪà³à²ªà²¿à²—ೆ ನೀಡಿರà³à²µà³à²¦à²¨à³à²¨à³ ನಾನೠದೃಢಪಡಿಸà³à²¤à³à²¤à³‡à²¨à³†. ಈ ವಿಷಯದಲà³à²²à²¿ ಯಾವà³à²¦à³‡ ಅನà³à²®à²¾à²¨à²—ಳಿದà³à²¦à²²à³à²²à²¿ ನನà³à²¨à²¨à³à²¨à³à²¸à²‚ಪರà³à²•à²¿à²¸à³à²µà²‚ತೆ ಕೇಳಿಕೊಳà³à²³à²²à²¾à²—ಿದೆ.
```
DR RASHMI
```
```
ASSISTANT PROFESSOR ,DEPARTMENT OF ANESTHESIOLOGY
```
**ಸಂಶೋಧಕರ ಹೆಸರà³:.....................................**
**ಸಂಶೋಧಕರ ಸಹಿ :..........................................**
**ದಿನಾಂಕ : (ದಿನ/ತಿಂಗಳà³/ವರà³à²·):........................**
**PROFORMA**
**A)****PATIENTS PROFILE:**
**Name: Diagnosis:**
**Age: Surgery:**
**Sex: Date of surgery:**
**IP No:**
**B) GENERALPHYSICAL EXAMINATION:**
**Weight: Height:**
**BMI:**
**Pulse: BP: RR: Temperature:**
**Pallor: Icterus: Cyanosis: Clubbing: Lymphadenopathy:**
**SYSTEMIC EXAMINATION:**
**CVS:**
**RS:**
**PA:**
Time ofadministration of bock:
Patientshifted out to the ward after hours ofsurgery.
Time ofgiving rescue analgesia:
Total dose ofrescue analgesic in 24hr:
Complicationsif any:
| | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|0
1 hr
2 hr
4 hr
6 hr
12 hr
24 hr
|
|
|VITALS:
SBP
|DBP
|MAP
|HR
|RR
| SPO2
Hematocri t and haemoglobin preoperative;Hematocrit and haemoglobin 24 hr posto
**Title of the project****:** Effect of Paravertebral Block on reducing bloodloss in Percutaneous Nephrolithotomy (PCNL)surgeries : Randomized Controlled Trial.
Dr Rashmi, Assistant professor, Department of anesthesiology and criticalcare, RRMCH, Bangalore
Dr. Shankar K, Assistant professor, Department of anesthesiology and Criticalcare, RRMCH, Bangalore
**NEED FOR STUDY**
Percutaneous nephrolithotomy(PCNL) is a minimally invasive urologicalprocedure done as treatment for kidney stones greater than 20mm or incircumstances where kidney stones are not broken by extra corpororeal shockwave lithotripsy1. The extraction of stones is done percutaneouslythrough a small incision leading to lesser morbidity and shortens hospital stay2.
Bleeding is one of the majorcomplication associated with percutaneous nephro lithotomy. Pelvicalycealsystem is opened up and intrarenal manipulations can cause injury to the renalvasculature, especially the interlobar and segmental arteries3.
Creating multiple tracts, diabetes, prolonged duration of surgery areassociated with increased blood loss4.
Methods like use of tranexamic acid and Mini percutaneous nephrolithotomyvia small percutaneous tract (11- 20 F) have been used to reduce blood loss butthe results are inconclusive5,6.
Paravertebral block with local anesthetics causes sympathetic nerveblock with reduces the pressures in the regional vasculature, decreases neuroendocrine stress response and there by reducing the blood loss 7.
Hence we are conducting this study to see the effectof unilateral paravertebral block given beforesurgery to reduce intra operative blood loss.
**REVIEW OF LITERATURE:**
**Kukreja** et al in 2004 did a study to determine factorsaffecting blood loss during percutaneous nephrolithotomy .It was a prospectivestudy which concluded preoperative hemoglobin , multiple tracts , stone size,and total blood loss were significant in predicting blood transfusionrequirement. Factors such as age, hypertension, renal insufficiency , urinarytract infection, the degree of hydronephrosis, stone bulk and function ofipsilateral kidney did not have anyaffect on blood loss4.
**Said** et al in 2016reviewed factors affecting total blood loss and need for blood transfusion in aseries of patient undergoing unilateral percutaneous nephrolithostomy. Itshowed factors which affecting rate of blood transfusion were intraoperative complications like perforationand extravasation, stone complexity, operative time and preoperative creatininelevel8.
**Syahputra** et al in 2016 conducted a study on blood loss predictive factors and transfusionpractice during percutaneous nephrolithostomy of kidney stones. It was aprospective randomised study which determined stone burden as major predictorof blood loss3.
**Meng et al** in 2019 analysed the risk factors for heamorrhage associated withminimally invasive percutaneous nephrolithostomy. Retrospective analysis determinedthat surgeons experience, stone size, staghorn calculi, operation time wererisk factors for bleeding intraoperatively9.
**Mohammadi** et al in 2019 studied effect of tranexamic acid onbleeding and hemoglobin levels in patients with staghorn calculi undergoingpercutaneous nephrolithotomy. This randomised controlled trial concluded thattranexamic acid reduced risk of bleeding and attenuated the drop in thehemoglobin level5.
**AIM:** To assess the efficacy of USG guidedunilateral paravertebral block for reduction of blood loss in PCNL surgeries
**Objectives –**
• Comparison of hemodynamic parameters.
• To study the safety profile of abovetechniques and the drugs used.
**MATERIALSAND METHODS****:**
A) **Study design**: Randomized control trial
B)**Study period**:3 month
B) **Place ofstudy**: Inpatients at hospitals attached toRajarajeswari Medical College and hospital, Bangalore.
C) **Sample size**: Afterconducting a pilot study average drop in the hemoglobin in was 2.5g/dl and 0.83g/dl in control group andparavertebral group respectively. Considering effect size as 1.6, alpha erroras 0.05 and power of 80%, 23 patients per group was obtained. To avoid studyattrition and errors 25 patients per group was taken up for study.
**E) Inclusion Criteria:**
1. Adult patients between 18-60yr of age ofeither sex.
2. ASA status Iand II
3. Undergoingunilateral PCNL surgeries.
**F)Exclusion Criteria:**
1. Patientsrefusing to participate in the study
2. Patient withuncontrolled hypertension, diabetes, cardio-respiratory disorders,neuro-psychiatric disorders, hepatic or renal dysfunction.
3.Coagulopathy, infection at the site of block, neurological deficits.
4. Patients onmedications like opioids, sedatives, anti-psychotics, anti-epileptics.
5. Pregnant orlactating mothers.
6.Alcoholic
7.Allergic tostudy drug
**Methodology of Study:**
Following approval of institutional ethical committee50 patients will be taken up for the study after testing negetive for COVID 19.Pre anesthetic evaluation will be done for all the patients and preoperativehemoglobin will be noted. Written informed consent will be taken. All patientswill be kept nil per oral for 8hrs.
In operation theatre standardmonitors will be attached and baseline parameters will be recorded. Thepatients are randomized with help of sealed opaque envelope technique into twogroups. Group C is taken as control group and Group P will receive ultrasoundguided unilateral paravertebral block.
In group P, paravertebral block will be performed in sitting position underultrasound guidance with 22G echogenic needle after identifying the landmarksat the T10-T11 levelsusing 20 ml of 0.375% ropivacaine. Thespread of the local anaesthetic will be confirmed by anterior movement of thepleura in the paravertebral space.
In the control group, no intervention was performed.All blocks will be performed by the same experienced anesthesiologist.
Patient will be placed in supine position andpremedicated with Injection midazolam 0.02mg/kg, glycopyrrolate 0.005mg/kg, andfentanyl 1-2mcg/kg 5min before induction. After pre oxygenation with 100% O2for 3-5min, patient will be induced with injection of propofol 2-2.5mg/kg tillthe loss of verbal commands. Neuromuscular blockade to facilitate placement ofendotracheal tube will be achieved by injection vecurronium 0.08-0.1mg/kg. Anaesthesia will be maintained with oxygen,nitrous oxide, isoflurane, and vecuronium. After the insertion of a urinary catheter, the patientswill be placed in the prone position for the surgery. Hemodynamicswill be monitored throughout the surgery. The patient will be placed back insupine position after completion of surgery, extubated after meeting theexubation criteria and shifted to post anesthesia care unit for monitoring.
Repeat hemoglobin will be performed 24 hours aftersurgery.
**STATISTICAL ANALYSIS**
Samplesize estimation: After conducting a pilot study average drop in thehemoglobin in was 2.5g/dl and 0.83g/dl in control group and paravertebral grouprespectively. Considering effect size as 1.6, alpha error as 0.05 and power of80%, 23 patients per group was obtained. To avoid study attrition and errors 25patients per group was taken up for study.
Statisticalanalysis will be done using SSPS software 16 version as follows:
Student T test will beused to compare nominal data between the groups.
Chi square test will beused to compare categorical data between the groups.
P value <0.05 willbe considered significantly.
**DOESTHE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED ONPATIENTS OR OTHERS HUMANS OR ANIMALS? IF SO, PLEASE DESCRIBE BRIEFLY**
The study doesn’trequire any intervention on animals.
Routineinvestigations relevant for surgery - Complete blood count, RBS, RFT, serumelectrolytes, ECG, chest X ray.
**LISTOF REFERENCES:**
1. Gupta M, Ost MS, Shah JB, et al. Percutaneousmanagement of upper urinary tract. In Wein AJ, et al (eds). Campbell WalshUrology, 9th ed. Philadelphia, Saunders Elsevier, 2007.
2.Carrion D, Cancino J R,Quintana L M, et al: Prone percutaneous nephro lithotomy: its advantage and ourtechnique for puncture. Transl Androl Urol. 2018 Dec; 7(6):950-959
3. Syahputra FA, Birowo P,Rasyid N, Matondang FA, Noviandrini E, Huseini MH. Blood loss predictivefactors and transfusion practice during percutaneous nephrolithotomy of kidneystones: a prospective study. *F1000Res*. 2016;5:1550. Published 2016 Jun30. doi:10.12688/f1000research.8993.
4. Kukreja R, Desai M, Patel S, Bapat S, Desai M. Factorsaffecting blood loss during percutaneous nephrolithotomy: Prospective study. J Endourol. 2004;18:715–722. doi:10.1089/0892779042360599.
5. Mohammadi Sichani M, KazemiR, Nouri-Mahdavi K, Gholipour F. **Re-evaluationof the efficacy of tranexamic acid in reducing blood loss in percutaneousnephrolithotomy: a randomized clinical trial.**Minerva Urol Nefrol. 2019;71(1):. <https://doi.org/10.23736/S0393-2249.18.03151-X>
6. Ferakis N, Stavropoulos M.Mini percutaneous nephrolithotomy in the treatment of renal and upper ureteralstones: Lessons learned from review of the literature. Urol Ann. 2015 Apr-Jun;7(2): 141-148
7. Batra RK, Krishnan K,Agarwal A. Paravertebral block. J Anaesthesiol Clin Pharmacol.2011 Jan-Mar;27(1):5-11.
8. Said S, Aghaways I, FryadG. Review of factors affecting total blood loss and need for blood transfusionin a series of patient undergoing unilateral percutaneous nephrolithotomy. UrolNephrol Open Access J. 2016;3(6):208-213
9. Meng X, Bao J, Mi Q et al:The analysis of risk factors for heamorrhage associated with minimally invasivepercutaneous nephrolithostomy.
| |
| --- |
|BioMed Research International. 2019;2019:1. <https://doi.org/10.1155/2019/8619460>
**CERTIFICATE**
Thedissertation topic “**Effect of paravertebral block on reducing bloodloss in percutaneous nephrolithotomy(PCNL) surgeries : Randomized controlledtrial****â€**
AtRajarajeshwari Medical College and Hospital, Bangalore by Dr. Priyanka D ,post-graduate student in the Department of Anesthesiology has been approved bythe institutional ethical committee, RAJARAJESWARI MEDICAL COLLEGE, BANGALORE.
**INFORMED CONSENT**
I, Dr. Rashmi, Assistant professor, Department of anaesthesiaconducting a randomized trial for award of MD degree in Anaesthesia. The topic of thestudy is: “**Determining effectiveness ofparavertebral block on blood loss inpercutaneous nephrolithotomy surgeries : a randomized controlled trial****â€**
I have been briefedon the foregoing research being conducted by Dr. Rashmi and it has beenconveyed to me in my own language .I have had the opportunity to ask questionsabout it & all questions that I have asked have been answered to mysatisfaction. I consent voluntarily to participate as a participant in thisresearch & understand that I have the right to withdraw from the researchat any time without in any way affecting my medical care.
Name of theparticipant:.......................................................................................... Signature of theparticipant: ..........................................................................................Date:(d/m/y).......................................................................................
If illiterate: A literate witnessmust sign ( If possible this person should be selected by the
participant andshould have no connection to the research team)I have read and witnessed theaccurate reading of the consent form to the potential participant and theindividual has had the opportunity to ask questions, I confirm that theindividual has given consent freely.
Name of thewitness................................................... Signature ofwitness.............................................. Date:(d/m/y)....................................................
Thumb impression ofparticipant
I have read andwitnessed the accurate reading of the consent form to the potential participantand the individual has had the opportunity to ask questions, I confirm that theindividual has given consent freely. In case of any doubt I have been asked tocontact: Dr. Rashmi, assistant professor indepartment of anaesthesiology
Name ofResearcher:...............................................................Signature of researcher:............................................................
Date :(d/m/y)........................................................................
**ತಿಳಿವಳಿಕೆಯà³à²³à³à²³ ಸಮà³à²®à²¤à²¿à²¨à²®à³‚ನೆ.**
**ನಾನà³, ಅರಿವಳಿಕೆ ಸà³à²¨à²¾à²¤à²•à³‹à²¤à³à²¤à²°à²µà²¿à²à²¾à²—ದ** ಡಾ RASHMI **ಅರಿವಳಿಕೆ ವಿಷಯದಲà³à²²à²¿à²¨** **‘****ಡಾಕà³à²Ÿà²°à³ ಆಫೠಮೆಡಿಸನà³****‌****‘****(ಎಂಡಿ) ಪದವಿಗಾಗಿ ನಡೆಸà³à²¤à³à²¤à²¿à²°à³à²µ****ಯಾದೃಚà³à²šà²¿à²•****ಪà³à²°à²¯à³‹à²—.**
**ಅಧà³à²¯à²¯à²¨ ವಿಷಯ:** “**Determiningeffectiveness of paravertebral block on blood loss in percutaneous nephrolithotomy surgeries : arandomized controlled trial****â€**
```
ಡಾ ಪà³à²°à²¿à²¯à²¾à²‚ಕಾ ಡಿ ನಡೆಸà³à²¤à³à²¤à²¿à²°à³à²µ ಸಂಶೋಧನೆ ಕà³à²°à²¿à²¤à³ ನಾನೠವಿವರಣೆಯನà³à²¨à³ ಪಡೆದಿದà³à²¦à³‡à²¨à³† ಮತà³à²¤à³ ಈ ವಿವರಣೆಯನà³à²¨à³ ನನಗೆ ನನà³à²¨ ಮಾತೃ à²à²¾à²·à³†à²¯à²²à³à²²à³‡ ನೀಡಲಾಗಿದೆ. ಅದರ ಬಗà³à²—ೆ ಪà³à²°à²¶à³à²¨à³†à²—ಳನà³à²¨à³ ಕೇಳಲೠನನಗೆ ಅವಕಾಶವನà³à²¨à³ ನೀಡಲಾಗಿತà³à²¤à³ ಮತà³à²¤à³ ನಾನೠಕೇಳಿದ ಎಲà³à²²à²¾ ಪà³à²°à²¶à³à²¨à³†à²—ಳಿಗೆ ತೃಪà³à²¤à²¿à²•à²°à²µà²¾à²—ಿ ಉತà³à²¤à²°à²—ಳನà³à²¨à³ ನೀಡಲಾಗಿದೆ. ನಾನೠಈ ಸಂಶೋಧನೆಯಲà³à²²à²¿ ಸಹà²à²¾à²—ಿಯಾಗಿ ಪಾಲà³à²—ೊಳà³à²³à²²à³ ಸà³à²µà²‡à²šà³à²›à³†à²¯à²¿à²‚ದ ಸಮà³à²®à²¤à²¿à²¸à²¿à²¦à³à²¦à³‡à²¨à³† ಮತà³à²¤à³ ಯಾವà³à²¦à³‡ ರೀತಿ ನನಗೆ ವೈದà³à²¯à²•à³€à²¯à²µà²¾à²—ಿ ತೊಂದರೆಯಾದರೆ ಯಾವà³à²¦à³‡ ಸಂದರà³à²à²¦à²²à³à²²à²¿ ಸಂಶೋಧನೆಯಿಂದ ಹಿಂದೆ ಸರಿಯà³à²µ ಹಕà³à²•à²¨à³à²¨à³ ಹೊಂದಿದà³à²¦à³‡à²¨à³†à²¨à³à²¨à³à²µà³à²¦à²¨à³à²¨à³ ಬಲà³à²²à²µà²¨à²¾à²—ಿದà³à²¦à³‡à²¨à³†.
```
**à²à²¾à²—ವಹಿಸà³à²µà²µà²° ಹೆಸರೠ:...................................................................**
**à²à²¾à²—ವಹಿಸà³à²µà²µà²°à³****ಸಹಿ :...................................................................**
**ದಿನಾಂಕ: ( ದಿನ/ತಿಂಗಳà³/ವರà³à²·):............................................................**
**ಅನಕà³à²·à²°à²¸à³à²¥à²°à²¾à²—ಿದà³à²¦à²²à³à²²à²¿:** ಒಬà³à²¬ ಅಕà³à²·à²°à²¸à³à²¥ ಸಹಿ ಮಾಡà³à²µà³à²¦à³à²•à²¡à³à²¡à²¾à²¯. (ಸಾಧà³à²¯à²µà²¾à²¦à²²à³à²²à²¿ ಈ ವà³à²¯à²•à³à²¤à²¿à²¯à²¨à³à²¨à³à²¸à²‚ಶೋಧನೆಯಲà³à²²à²¿ à²à²¾à²—ವಹಿಸà³à²µà²µà²°à³
ಆಯà³à²•à³†à²®à²¾à²¡à²¬à³‡à²•à³ ಮತà³à²¤à³ ಸಂಶೋಧನಾ ತಂಡದ ಜೊತೆಈತ ಯಾವà³à²¦à³‡ ಸಂಪರà³à²• ಹೊಂದಿರಬಾರದà³).
ನಾನೠಸಮà³à²®à²¤à²¿ ನಮೂನೆಯನà³à²¨à³à²“ದಿದà³à²¦à³‡à²¨à³† ಮತà³à²¤à³ ನಿಖರವಾಗಿ ಓದಿರà³à²µà³à²¦à²¨à³à²¨à³ ಸಾಕà³à²·à³€à²•à²°à²¿à²¸à²¿à²¦à³à²¦à³‡à²¨à³†. ಸಂಶೋಧನೆಯ ಸಂà²à²¾à²µà³à²¯ ಅà²à³à²¯à²°à³à²¥à²¿à²—ೆಓದಿ ತಿಳಿಸಲಾಗಿದà³à²¦à³, ಅವರ ಸಂಶಯಗಳನà³à²¨à³ ಪರಿಹರಿಸಿಕೊಳà³à²³à²²à³, ಪà³à²°à²¶à³à²¨à³†à²—ಳನà³à²¨à³ ಕೇಳಲೠಅವಕಾಶ ನೀಡಲಾಗಿತà³à²¤à³.à²à²¾à²—ವಹಿಸà³à²µà²µà²°à³ ಮà³à²•à³à²¤à²µà²¾à²—ಿ ಒಪà³à²ªà²¿à²—ೆ ನೀಡಿರà³à²¤à³à²¤à²¾à²°à³†à²‚ಬà³à²¦à²¨à³à²¨à³ ನಾನೠದೃಢಪಡಿಸà³à²¤à³à²¤à³‡à²¨à³†.
**ಸಾಕà³à²·à²¿à²¯ ಹೆಸರà³......................................**
**ಸಾಕà³à²·à²¿à²¯ ಸಹಿ ......................................**
**ದಿನಾಂಕ : (ದಿನ/ತಿಂಗಳà³/ವರà³à²·):........................** **à²à²¾à²—ವಹಿಸà³à²µà²µà²°à²¹à³†à²¬à³à²¬à³†à²Ÿà³à²Ÿà²¿à²¨ ಗà³à²°à³à²¤à³**
ನಾನೠಇದನà³à²¨à³ ಓದಿದà³à²¦à³‡à²¨à³†à²®à²¤à³à²¤à³ à²à²¾à²—ವಹಿಸà³à²µà²µà²°à²¿à²—ೆ ಸಮà³à²®à²¤à²¿ ನಮೂನೆಯನà³à²¨à³ ನಿಖರವಾಗಿ ಓದಿರà³à²µà³à²¦à²¨à³à²¨à³ ಸಾಕà³à²·à³€à²•à²°à²¿à²¸à²¿à²¦à³à²¦à³‡à²¨à³†.à²à²¾à²—ವಹಿಸà³à²¤à³à²¤à²¿à²°à³à²µà²µà²°à³ ಪà³à²°à²¶à³à²¨à³†à²—ಳನà³à²¨à³ ಕೇಳಲೠಅವಕಾಶ ನೀಡಲಾಗಿದೆ. à²à²¾à²—ವಹಿಸà³à²µà²µà²°à³ ಸà³à²µ ಪà³à²°à³‡à²°à²£à³†à²¯à²¿à²‚ದಒಪà³à²ªà²¿à²—ೆ ನೀಡಿರà³à²µà³à²¦à²¨à³à²¨à³ ನಾನೠದೃಢಪಡಿಸà³à²¤à³à²¤à³‡à²¨à³†. ಈ ವಿಷಯದಲà³à²²à²¿ ಯಾವà³à²¦à³‡ ಅನà³à²®à²¾à²¨à²—ಳಿದà³à²¦à²²à³à²²à²¿ ನನà³à²¨à²¨à³à²¨à³à²¸à²‚ಪರà³à²•à²¿à²¸à³à²µà²‚ತೆ ಕೇಳಿಕೊಳà³à²³à²²à²¾à²—ಿದೆ.
```
DR RASHMI
```
```
ASSISTANT PROFESSOR ,DEPARTMENT OF ANESTHESIOLOGY
```
**ಸಂಶೋಧಕರ ಹೆಸರà³:.....................................**
**ಸಂಶೋಧಕರ ಸಹಿ :..........................................**
**ದಿನಾಂಕ : (ದಿನ/ತಿಂಗಳà³/ವರà³à²·):........................**
**PROFORMA**
**A)****PATIENTS PROFILE:**
**Name: Diagnosis:**
**Age: Surgery:**
**Sex: Date of surgery:**
**IP No:**
**B) GENERALPHYSICAL EXAMINATION:**
**Weight: Height:**
**BMI:**
**Pulse: BP: RR: Temperature:**
**Pallor: Icterus: Cyanosis: Clubbing: Lymphadenopathy:**
**SYSTEMIC EXAMINATION:**
**CVS:**
**RS:**
**PA:**
Time ofadministration of bock:
Patientshifted out to the ward after hours ofsurgery.
Time ofgiving rescue analgesia:
Total dose ofrescue analgesic in 24hr:
Complicationsif any:
| | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|0
1 hr
2 hr
4 hr
6 hr
12 hr
24 hr
|
|
|VITALS:
SBP
|DBP
|MAP
|HR
|RR
| SPO2
Hematocri t and haemoglobin preoperative;Hematocrit and haemoglobin 24 hr postopertive
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 50
ASA status I and II Undergoing unilateral PCNL surgeries.
- Patients refusing to participate in the study 2.
- Patient with uncontrolled hypertension, diabetes, cardio-respiratory disorders, neuro-psychiatric disorders, hepatic or renal dysfunction.
- Coagulopathy, infection at the site of block, neurological deficits.
- Patients on medications like opioids, sedatives, anti-psychotics, anti-epileptics.
- Pregnant or lactating mothers.
- 6.Alcoholic 7.Allergic to study drug.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To Determine Reduction in Blood loss in patients receiving Paravertebral Block prior to PCNL Surgery. To Determine Reduction in Blood loss in patients receiving Paravertebral Block prior to PCNL Surgery. 3 Months
- Secondary Outcome Measures
Name Time Method To Check Safety Profile of Paravertebral Block in PCNL Surgery in regards to Hemodynamic Parameters 3 Months
Trial Locations
- Locations (1)
RajaRajeswari Medical College and Hospital
🇮🇳Bangalore, KARNATAKA, India
RajaRajeswari Medical College and Hospital🇮🇳Bangalore, KARNATAKA, IndiaDr RashmiPrincipal investigator9986665368rashmi.rp16@gmail.com