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

NCT05231941 | Completed DMC

• 1 other identifier: 5515
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• 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

Study Arms (3)

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.

Drug: Lidocaine IV

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.

Drug: Ropivacaine

Control group

NO INTERVENTION

No additional intervention will be given to this group

Interventions

Lidocaine IV DRUG

Bolus and infusion of lidocaine will be administered

Lidocaine Group

Ropivacaine DRUG

Bilateral TAP block will be given to these patients

TAP group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aga Khan University Hospital, Pakistan: lead

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, 74450, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Haris Sheikh, MBBS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-Graduate Trainee, Department of Anaesthesiology

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 9, 2022
• Study Start: February 25, 2022
• Primary Completion: October 17, 2022
• Study Completion: October 17, 2022
• Last Updated: June 26, 2024

Record last verified: 2024-06

Locations

PA (1)