Comparative study of two different combination of anaesthetic drugs for spinal anaesthesia
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2023/06/054533
- Lead Sponsor
- CHETTINAD HOSPITAL AND RESEARCH INSTITUTE
- Brief Summary
**INTRODUCTION**
Spinal anaesthesia is a commonly used and effectivetechnique which provides rapid and reliable anaesthesia with muscle relaxationfor patients undergoing lower abdominal and lower limb surgeries.[1]
Theadvantages of spinal anaesthesia include a faster initiation of action whenequated with epidural blocks, as well as the simplicity and ease ofadministration. The benefits are they reduce the risk of DVT, PE, coronaryproblems, oozing of blood, need for transfusions, and depression inrespiration, provides greater relief of pain following surgery.[2]
Inthe recent days, Ropivacaine is gaining increasing popularity because ofreduced risk of central nervous system and cardiotoxicity, early ambulation anddischarge with good quality of post-operative analgesia.[3]
Ropivacaineis a pure S(-) enantiomer of propyl derivative of pipecoloxylidide and a newlong- acting amino amide with lower lipid solubility and cardiotoxicity thanBupivacaine. [4,5]
Isobaricform produces variable form of sensory and motor blockade whereashypothetically, Hyperbaric Ropivacaine produces more reliable sensory and motorblockade with faster onset, better quality of muscle relaxation than IsobaricRopivacaine. [6]
Buprenorphineis an opioid of the phenanthrene morphine class with extremely high bindingaffinity and a partial agonist activity at the μ- and κ-receptors and partial or full agonistactivity at the opioid receptor like I/nociception and λ- receptor and competitive antagonistactivity at the κ-receptor. [7]
**AIMAND OBJECTIVES**
**AIM:**
To compare the efficacyof intrathecal HyperbaricRopivacaine (0.75%) and Isobaric Ropivacaine (0.75%) with Buprenorphine inpatients undergoing lower abdominal and lower limb orthopedic procedures underSubarachnoid block.
**OBJECTIVES**:
**Primary objective:**
• Tocompare onset and duration of sensory and motor blockade.
• Toassess and compare the haemodynamic parameters between both groups.
**Secondary objective:**
• Toassess two segment sensory regression time.
• Sideeffects if any.
**MATERIALS ANDMETHODS**
**STUDY TYPE**
Interventional
**STUDY DESIGN**
A prospective randomizeddouble-blind study.
**STUDY POPULATION**
After Ethical Committeeapproval and CTRI registration, 70 patients who will undergo elective oremergency lower abdominal and lower limb surgeries at Chettinad Hospital andResearch Institute, Kelambakkam, Chennai, will be taken up for study.
**SAMPLE SIZE**
The sample size iscalculated for the two independent study group for Continuous variables forrandomised control trial using the formula for Non- Inferiority design.
N=2\*(Z1- α+Z1- β/ δ0)2\*s2
• N-size per group
• Z-Standard normal deviate
• δ0-Allowable difference
• s2- polled standarddeviation of comparison groups
• α- Type 1 error
• β- Type 2 error
• Thesample size is based on the previous study in which the Mean (± SD) onset ofsensory blockade (T10) was faster in patients receiving Hyperbaric Ropivacaine(0.75%) (4.42± 1.33) than in patients receiving Isobaric Ropivacaine (0.75%)(6.0± 1.03), study by Gupta et al.
• **Samplesize:** 70
• **GroupA=**35 patients; **Group B=** 35 patients
Where
• Confidenceinterval 90% α=0.10
• Power (1-β)=0.30
• Ratio of sample size, Treat/control=1
• SD=1.3; Drop out (%)=10%
• Allowable difference= 1.6 (Comparative study ofintrathecal Hyperbaric Ropivacaine (0.75%) and Isobaric Ropivacaine (0.75%)with Buprenorphine in patients undergoing lower abdominal and lower limbprocedures under Subarachnoid block)
• Thesample size calculated per group
Group A = 35; Group B = 35
• Patientsin each group will receive anaesthesia as follows:
• **GroupA (n= 35) :**Patientswill receive 3.5 ml of Hyperbaric Ropivacaine (0.75%) + 0.2 ml Buprenorphine(60mcg)
• **GroupB (n= 35) :**Patientswill receive 3.5 ml of Isobaric Ropivacaine (0.75%) + 0.2 ml Buprenorphine(60mcg)
**Inclusion criteria**
1. American Society of Anesthesiologists (ASA) gradeI-III.
2. Age group between 18-60 years of both sexes.
3. Scheduled for Elective and emergency lowerabdominal and lower limb surgeries under Spinal Anaesthesia.
**Exclusion criteria**
1.Patient refusal
2.History of allergy to study drugs
3.Post spinal surgeries, Spinal Deformities, skin sepsis in lumbar region,patients with pre-existing neurological disorders.
4.Coagulopathy, Dysrhythmia
5.Major Hepatic, Renal and Cardiovascular Dysfunction
6.BMI >35, Height <140cm
7.Surgeries involving major blood loss
**METHODOLODY**
The enrolled subjects will be randomized into the 2study groups using computer generated randomization code.
All the patients will receive Tab Alprazolam 0.5mg HSand Tab Ranitidine 150mg HS and 6am in the morning of surgery.On arrival in Pre-op area anIV access with 18G IV cannula will be secured and RL will be started.
Establishment of proper standard monitoring systems(pulse oximetry, continuous electrocardiography and non-invasive blood pressuremonitoring and SpO2).
Sitting position is recommended for all patientsincluded in this study. Under all aseptic precautions L3-L4 inter-space will beinfiltrated with 2ml of 2% Inj. Lignocaine.
Study drug will be prepared by the person not involvedin the study. The subarachnoid space will be entered at **L3-L4intervertebral-space** via the midline approach using **26-Gauge Quincke**spinal needle. The correct needle placement will be identified by free flow ofcerebrospinal fluid and 3.7 ml of study drug will be injected by theanesthesiologist.
The patient will be placed in supine position to carryover the initial assessment. The onset of sensory and motor blockade will beassessed at baseline and 3 min interval up to 15 min.
The **onset of sensory blockade** will beconsidered as loss of cold sensations at T10 level and the highest level ofsensory blockade will also be noted.The **onset of motor blockade** will beevaluated using Modified Bromage score of 2.Two segment sensory blockade andthe regression of Motor Blockade to score of 0 will be noted at the end of theprocedure.
The **duration of sensory blockade** is taken asthe two segment regression and the **duration of motor block** is takenModified Bromage score of 0.
The **duration of analgesia** is taken as the timetaken for the first analgesic need for the patient.
Continuous Vital monitoring includes patient’s HR,NIBP, RR and SpO2 will be monitored at 3 min interval up to 15 minutes thenevery 5 minutes up to 30 minutes.
The Modified Bromage score and level of sensoryblockade will be noted for every 30 min up to 5 hrs.
**POST- OPERATIVE PAIN AND SIDE EFFECTS**
• Post-surgery, the time for request of first rescueanalgesia will be noted from the time of administration of spinal anaesthesiato complain of pain VAS score of >/=3 (i.e. 0=No Pain, 10=worst imaginablepain).
• In case of Pain Inj. Tramadol 50 mg will be givenintravenously.
• Side effects such as nausea and vomiting will betreated using Inj. Ondensetron 4mg IV, Bradycardia by Inj. Atropine 0.6mg andHypotension by adequate fluids or if required Inj. Ephedrine 6mg.
**REFERENCES**
1. O’Connor PJ, Hanson J, Finucane BT. Induced hypotension with epidural/general anesthesia reduces transfusion in radical prostate surgery. Can J Anaesth 2006;53:873‑80.
2. Mattoo P, Chowdhary A, Mehta N, Chopra V.Comparison of the effect of intrathecal 0.5% isobaric bupivacaine and 0.5%isobaric levobupivacaine in patients undergoing lower abdominal and lower limbsurgeries. JOURNAL OF EVOLUTION OF MEDICAL AND DENTAL SCIENCES-JEMDS. 2016 Sep26;5(77):5668-72.
3. Sultan MA, Ali Shams TM, Mageed NA, El‑ebidy MG. Intrathecal hyperbaric ropivacaine versus hyperbaric bupivacaine in geriatric hypertensive patients. Benha M. J. 2005;22:479.
4. Rattenberry W, Hertling A, Erskine R. Spinal anaesthesia for ambulatory surgery. BJA Educ. 2019 Oct;19(10):321-328. doi: 10.1016/j.bjae.2019.06.001. Epub 2019 Aug 13. PMID: 33456853; PMCID: PMC7807930.
5. Latwal BS, Singam A, Shrey S, et al. A comparative study of intrathecal 0.5% hyperbaric bupivacaine & intrathecal 0.75% isobaric ropivacaine in lower abdominal surgeries. J. Evolution Med. Dent. Sci. 2020;9(05):256-261, DOI: 10.14260/jemds/2020/58
6. Gupta R, Bogra J, Singh PK, Saxena S, Chandra G, Kushwaha JK. Comparative study of intrathecal hyperbaric versus isobaric ropivacaine: A randomized control trial. Saudi J Anaesth 2013;7:249-53.
7. Singh AP, Kaur R, Gupta R, Kumari A. Intrathecal buprenorphine versus fentanyl as adjuvant to 0.75% ropivacaine in lower limb surgeries. J Anaesthesiol Clin Pharmacol 2016;32:229-33.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 70
- American Society of Anesthesiologists (ASA) grade I-III.
- Age group between 18-60 years of both sexes.
- Scheduled for Elective and emergency lower abdominal and Lower limb surgeries under Spinal Anaesthesia.
- Patient refusal 2.
- History of allergy to study drugs 3.
- Post spinal surgeries, Spinal Deformities, skin sepsis in lumbar region, patients with pre-existing neurological disorders.
- Coagulopathy, Dysrhythmia 5.
- Major Hepatic, Renal and Cardiovascular Dysfunction 6.
- BMI >35, Height <140cm 7.
- Surgeries involving major blood loss.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare onset & duration of sensory and motor blockade and to assess and compare the haemodynamic parameters between both groups. Intraoperatively & 5 hours postoperatively
- Secondary Outcome Measures
Name Time Method To assess two segment sensory regression time & side effects if any Intraoperatively & 5 hours postoperatively
Trial Locations
- Locations (1)
CHETTINAD ACADEMY OF RESEARCH AND EDUCATION
🇮🇳Chennai, TAMIL NADU, India
CHETTINAD ACADEMY OF RESEARCH AND EDUCATION🇮🇳Chennai, TAMIL NADU, IndiaKEERTHANAA PPrincipal investigator7798201876dr.keerthanaa97@gmail.com