Skip to main content
Clinical Trials/NCT05231941
NCT05231941CompletedNot Applicable

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

Aga Khan University Hospital, Pakistan1 site in 1 country90 target enrollmentStarted: February 25, 2022Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
90
Locations
1
Primary Endpoint
Pain score

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Lidocaine Group

Experimental

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.

Intervention: Lidocaine IV (Drug)

TAP group

Experimental

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.

Intervention: Ropivacaine (Drug)

Outcomes

Primary Outcomes

Pain score

Time Frame: At 12 hours

Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)

Pain Score

Time Frame: At 24 hours

Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)

Secondary Outcomes

  • Post operative nausea and vomiting(On arrival, At 2 hours, 4 hours, 6 hours, 12 hours and 24 hours)
  • Patient Satisfaction(At 24 hours or discharge)

Investigators

Sponsor
Aga Khan University Hospital, Pakistan
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Haris Sheikh

Post-Graduate Trainee, Department of Anaesthesiology

Aga Khan University Hospital, Pakistan

Study Sites (1)

Loading locations...

Similar Trials