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

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.

Study Overview

• Status: Completed
• Conditions: Post Operative Pain
• Intervention / Treatment: Drug: Lidocaine IV; Drug: Ropivacaine

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sind
    • Karachi, Sind, Pakistan, 74450
      • Aga Khan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine Group; 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.	Drug: Lidocaine IV; Bolus and infusion of lidocaine will be administered
Experimental: TAP group; 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.	Drug: Ropivacaine; Bilateral TAP block will be given to these patients
No Intervention: Control group; No additional intervention will be given to this group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)	On arrival in PACU (0 hours)
Pain score	Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)	At 2 hours
Pain score	Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)	At 4 hours
Pain score	Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)	At 6 hours
Pain score	Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)	At 12 hours
Pain Score	Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)	At 24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Aga Khan University Hospital, Pakistan
• Investigators: Principal Investigator: Haris Sheikh, MBBS, Aga Khan University

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2022
• Primary Completion (Actual): October 17, 2022
• Study Completion (Actual): October 17, 2022

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: January 30, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Ropivacaine
• Other Study ID Numbers: 5515

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No