Irrigation of Bupivacaine at the Surgical Bed for Postoperative Pain Relief After Laparoscopic Cholecystectomy for Acute Cholecystitis

NCT07851935 | Completed Phase 4 DMC

• 1 other identifier: 11150925UASUR
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the effectiveness of irrigation of 0.5% bupivacaine versus normal saline at the gallbladder surgical bed in reducing postoperative pain following laparoscopic cholecystectomy for acute cholecystitis. Postoperative pain remains a common concern despite the minimally invasive nature of laparoscopic surgery. The study evaluates pain intensity at 4, 8, and 12 hours after surgery using the Visual Analogue Scale (VAS).

Conditions

Acute Cholecystitis; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Intensity at 12 Hours

  Pain intensity measured on a 0-10 Visual Analogue Scale (VAS), where 0 means no pain and 10 means the worst imaginable pain. Lower scores indicate less pain.

  12 hours after surgery

Secondary Outcomes (1)

• Number of Participants With Adverse Effects

  Up to 12 hours after surgery

Study Arms (2)

Normal Saline Irrigation Group

PLACEBO COMPARATOR

Patients received 20 mL of 0.9% normal saline irrigated over the gallbladder bed using the same technique and timing as the bupivacaine group. Postoperative analgesia was standardized with scheduled intravenous non-steroidal anti-inflammatory drugs, with weak opioids as rescue.

Drug: Normal Saline 0.9%

Bupivacaine Irrigation Group

EXPERIMENTAL

Patients received 20 mL of 0.5% bupivacaine irrigated over the gallbladder bed through the lateral-most port immediately after specimen retrieval, before desufflation and port closure. Postoperative analgesia was standardized with scheduled intravenous non-steroidal anti-inflammatory drugs, with weak opioids as rescue.

Drug: Bupivacaine 0.5%

Interventions

Bupivacaine 0.5% DRUG

20 mL of 0.5% bupivacaine irrigated over the gallbladder bed through the lateral-most port after specimen retrieval, before desufflation and port closure.

Bupivacaine Irrigation Group

Normal Saline 0.9% DRUG

20 mL of 0.9% sodium chloride irrigated over the gallbladder bed using the same technique and timing as the bupivacaine group.

Normal Saline Irrigation Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 60 years
• Acute cholecystitis confirmed by clinical findings (epigastric pain, abdominal tenderness, positive Murphy sign), ultrasound or CT findings (gallbladder wall thickening, pericholecystic fluid), and raised total leucocyte count and C-reactive protein
• Planned for laparoscopic cholecystectomy
• American Society of Anesthesiologists (ASA) physical status I or II
• Presentation within one week of symptom onset
• Able to provide written informed consent

You may not qualify if:

• Known allergy to amide local anaesthetics
• Uncontrolled hypertension
• Documented psychiatric disorder
• Gallbladder empyema, mucocele, or perforation
• Conversion to open cholecystectomy

Sponsors & Collaborators

• Ziauddin University: lead

Study Sites (1)

Dr. Ziauddin Hospital

Karachi, Sindh, 75600, Pakistan

Location

MeSH Terms

Conditions

Cholecystitis, Acute; Pain, Postoperative

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 1, 2026
• Study Start: October 1, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting after publication of the results and available for 5 years.
• Access Criteria: Requests should be sent to the Principal Investigator with a brief research proposal. Data will be shared after approval by the investigators, subject to Ziauddin University Ethics Review Committee requirements.

Locations

PA (1)