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

NCT ID: NCT05231941

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-25
• Study Completion Date: 2022-10-17

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.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Lidocaine IV

Intervention Type: DRUG

Bolus and infusion of lidocaine will be administered

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.

Group Type: EXPERIMENTAL

Ropivacaine

Intervention Type: DRUG

Bilateral TAP block will be given to these patients

Control group

No additional intervention will be given to this group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lidocaine IV

Bolus and infusion of lidocaine will be administered

Intervention Type: DRUG

Ropivacaine

Bilateral TAP block will be given to these patients

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aga Khan University Hospital, Pakistan

OTHER

Sponsor Role: lead

Responsible Party

Haris Sheikh

Post-Graduate Trainee, Department of Anaesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haris Sheikh, MBBS

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Locations

Aga Khan University Hospital

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

5515

Identifier Type: -

Identifier Source: org_study_id