Comparative study between injecting local anesthetic in the chest wall fascial plane and injecting local anesthetic agent at inertion site of key hole procedure instruments for Post-operative Analgesia in patients undergoing key hole cholecystectomy operation

Not yet recruiting

Conditions: Administration, (2) ICD-10 Condition: O||Medical and Surgical,

Registration Number: CTRI/2023/05/052421

Lead Sponsor: DR ARCHITA PATIL

Brief Summary: INTRODUCTION:

Laparoscopic cholecystectomy requires multiple port site incisions on anterior abdominal wall in the region of dermatomes T6-T10 leading to somatic pain in the post operative period. Analgesia is provided in the post-operative period by various alternatives like parenteral opioids and NSAIDS along with local anaesthetic infiltration of port sites. To reduce opioid consumption, local anaesthetics can be infiltrated in Fascial planes of abdomen using ultrasound guidance.

JUSTIFICATION AND RESEARCH PROBLEM:

Anterior and lateral part of upper abdominal wall are not reliably blocked by the Transversus Abdominis Plane (TAP) block [1,2]. A subcostal approach has been shown to block mid abdomen area in T7-12[1] Deeper blocks like Erector spinae and Quadratus lumborum are difficult to perform, require lateral positioning of the patient and cannot be given in patients with coagulopathy. External Oblique fascial plane is superficial in location and well visualised on USG. Cadaveric studies demonstrate its ability to block dermatomes in the supraumbilical region.[3]

Hence, we need to study effect of the block in post-operative period.

AIM: To compare the post-operative analgesic effect of ultrasound guided external oblique intercostal fascial plane block with port site infiltration for laparoscopic cholecystectomy.

OBJECTIVES:

1. To study pain score on Visual Analogue Scale (VAS) post-operatively after laparoscopic cholecystectomy in first 24 hours after administration of external oblique intercostal block.

2. To study pain score on Visual Analogue Scale (VAS) post-operatively after laparoscopic cholecystectomy in first 24 hours after administration of port site infiltration.

3. To compare pain scores in both the groups.

4. To study the total requirement of Inj.Tramadol for post-operative pain in first 24 hours in both the groups.

STUDY TECHNIQUE: Participants fulfilling inclusion criteria after written informed consent will be enrolled in the study. Pre-operative evaluation and routine investigations of CBC, Blood sugar, S.creatinine and ECG will be carried out to grade the ASA status. By computer generated random sampling, patients will be assigned to either Group A (External Oblique Intercostal Block) or Group B (Port Site Infiltration). Patients will be blinded to the group they are allotted to. Patients will be counselled for VAS score charting. In the operating room, 20 G Intravenous cannula will be secured and monitors attached to record baseline readings of pulse, blood pressure, ECG and SPO2. Standard anaesthesia protocol will be followed. Patient will be given Inj.Glycopyrollate 0.2 mg and Inj. Fentanyl 100 mcg as pre-medication. Induction agent Inj. Propofol 100 mg and Inj. Succinyl choline 75 mg IV will be given. Intubation with adequate sized cuffed endotracheal tube. Cuff will be inflated and tube secured with tape. Maintenance of anaesthesia will be carried out using O2: Air mixture with FiO2 50%, Sevoflurane 2.5%, and Inj. Vecuronium 4mg and repeated intermittently at 30 min intervals with top up doses of 1mg.

At the end of surgery, patients in Group A, will receive unilateral right sided External Oblique Intercostal Fascial Plane Block. Under all aseptic precautions, using ultrasound with linear probe, external oblique muscle will be identified in anterior axillary line on right side at the level of 6th or 7 th rib. A 22G spinal needle will be inserted and fascial plane beneath external oblique targeted. 20 ml of 0.25% inj. Bupivacaine will be injected after negative aspiration for blood and proper plane visualization. Complications during block placement will be noted will be pneumothorax or signs of local anaesthetic toxicity like arrhythmias and cardiac arrest.

Patients in Group B will receive 20ml of 0.25% bupivacaine infiltrated at port sites subcutaneously.

Patient will be reversed with Inj. Neostigmine 2.5 mg and Inj. Glycopyrollate 0.4mg after stopping all inhalational agents and attempts at spontaneous respiration and extubated. Post-operative monitoring in recovery for next two hours will be done. Postoperative VAS score will be observed in recovery and ward. Staff nurse will be instructed to record pain scores and note first time of analgesic requirement. When patient demands analgesia, Inj. Tramadol 100 mg IV will be given at intervals of 8 hours and not sooner. If pain is not relieved with tramadol after 1 hour, Inj. Diclofenac Sodium will be given 75 mg IM. Total doses of Tramadol in first 24 hours will be noted.

Visual Analogue Score (VAS) will be observed at 2 hours, 4 hours, 8 hours and 24 hours interval.

Time to demand of first rescue analgesic will be noted.

Total doses of Inj. Tramadol and Diclofenac will be noted.

REFERENCES:

1. Chen Y, Shi K, Xia Y, Zhang X, Papadimos TJ, Xu X, Wang Q. Sensory Assessment and Regression Rate of Bilateral Oblique Subcostal Transversus Abdominis Plane Block in Volunteers. Reg Anesth Pain Med. 2018 Feb;43(2):174-179. doi: 10.1097/AAP.0000000000000715. PMID: 29278604.

2. ArÄ±k, E., Akkaya, T., Ozciftci, S. et al. Unilateral transversus abdominis plane block and port-site infiltration. Anaesthesist 69, 270â€“276 (2020). <https://doi.org/10.1007/s00101-020-00746-1>

3. Hensham Elsharkawy, Sree Kolli, Loran Mounir Soliman, John Seif, Richard Drake, The External Oblique Intercostal Block; Anatomic Evaluation and Case series, Pain Medicine, Volume 22, Issue 11, November 2021, Pg2436-2442

4. Baral B, Poudel PR. Comparison of Analgesic Efficacy of Ultrasound Guided Subcostal Transversus Abdominis Plane Block with Port Site Infiltration Following Laparoscopic Cholecystectomy. J Nepal Health Res Counc. 2019 Jan 28;16(41):457-461. PMID: 30739941

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

Elective laparoscopic cholecystectomy.

Exclusion Criteria

1 Pregnancy 2 Coagulation disorders.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1 To know pain score on Visual Analogue Scale (VAS) post-operatively after laparoscopic cholecystectomy in first 24 hours after administration of external oblique intercostal block.	Visual Analogue Score (VAS) will be observed at 2 hours, 4 hours, 8 hours and 24 hours interval.
2 To study the total requirement of Inj.Tramadol for post-operative pain in first 24 hours	Visual Analogue Score (VAS) will be observed at 2 hours, 4 hours, 8 hours and 24 hours interval.

Secondary Outcome Measures

Name	Time	Method
1 To know pain score on Visual Analogue Scale (VAS) post-operatively after laparoscopic cholecystectomy in first 24 hours after administration of port site infiltration.	2 To study the total requirement of Inj.Tramadol for post-operative pain in first 24 hours

Trial Locations

Locations (1): D Y PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH INSTITUTE
🇮🇳
Kolhapur, MAHARASHTRA, India
D Y PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH INSTITUTE
🇮🇳Kolhapur, MAHARASHTRA, India
DR ARCHITA PATIL
Principal investigator
9326853458
drarchita@yahoo.co.uk