Comparison of Intraoperative Intravenous Lidocaine Infusion and Transversus Abdominis Plane (TAP) Block for Post-operative Analgesia Following Laproscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Post Operative Pain
• Interventions: Drug: Lidocaine IV; Drug: Ropivacaine

• Registration Number: NCT05231941
• Lead Sponsor: Aga Khan University Hospital, Pakistan

Brief Summary

This study is aimed to determine the post operative pain after laparoscopic cholecystectomy by dividing patients into three different group. Group A will receive lidocaine 2mg/kg bolus at induction followed by 1.5mg/kg/hr infusion. Group B will receive bilateral subcostal TAP block with 0.375% 20ml Ropivicaine on each side. Group C will not receive any additional pain regime apart from the routine intraoperative analgesics. Pain score will be assessed post operatively for 24 hours at regular intervals using visual analog score.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-19
• Study First Submitted QC: 2022-01-30
• Study First Posted: 2022-02-09
• Study Start: 2022-02-25
• Primary Completion: 2022-10-17
• Study Completion: 2022-10-17
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Age group (18-65)
• Undergoing elective Laproscopic Cholecystectomy
• ASA status I or II

Exclusion Criteria

• Participation in any other trial
• Known hypersensitivity to study medications
• Chronic Opioid used
• Seizure disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine Group	Lidocaine IV	After induction of anaesthesia, a bolus of 2mg/kg intravenous lidocaine will be given followed by Lidocaine infusion at the rate of 1.5 mg/kg/hour which will be stopped at the end of surgery.
TAP group	Ropivacaine	After completion of procedure and before extubation, bilateral ultrasound guided subcoastal transversus abdominis plane (TAP) block will be performed by the primary anaesthetist. After taking aseptic measures, with patient in supine position a high frequency (6-13 MHz) linear ultrasound probe will be placed obliquely just inferior to the costal margin over the anterior abdominal wall. With the help of a 21G or 22G, 100 mm needle, 20 ml of 0.375% Ropivacaine will be injected between rectus sheath and fascia of transversus abdominis muscle, bilaterally.

Primary Outcome Measures

Name	Time	Method
Pain score	At 12 hours	Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)
Pain Score	At 24 hours	Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)

Secondary Outcome Measures

Name	Time	Method
Post operative nausea and vomiting	On arrival, At 2 hours, 4 hours, 6 hours, 12 hours and 24 hours	Nausea and vomiting score would be assess using Bellville scoring system (0: No nausea or vomiting, 1: nausea, 2: nausea and belching, 3: vomiting)
Patient Satisfaction	At 24 hours or discharge	Patient satisfaction will be assessed on Likert Scale (Completely Disagree, Disagree, Neutral, Agree, Completely Agree)

Trial Locations

Locations (1)

Aga Khan University Hospital; 🇵🇰 Karachi, Sind, Pakistan