Postoperative Pain After Instillation Of Bupivacaine During Laparoscopic Cholecystectomy

NCT07098429 | Completed Phase 4 DMC

• 1 other identifier: IHHN _IRB_2024_04_002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the level of postoperative pain experienced by patients undergoing laparoscopic cholecystectomy with and without the use of intraperitoneal bupivacaine. Bupivacaine, a long-acting local anesthetic, is hypothesized to reduce postoperative pain when instilled into the peritoneal cavity at the end of the procedure. The study will involve adult patients undergoing elective laparoscopic cholecystectomy and will assess pain levels using standardized pain scoring methods at various postoperative intervals. By evaluating and comparing outcomes in both groups, the study seeks to determine whether the routine use of intraperitoneal bupivacaine provides significant analgesic benefits, contributing to enhanced recovery and improved patient comfort following surgery

Conditions

Laparoscopic Cholecystectomy; Post Operative Analgesia; Bupivacaine

Keywords

Laparoscopic Cholecystectomy Analgesia; Gallstones; Outcomes; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Pain Assessment after Laparoscopic Cholecystectomy

  After instillation of drug, pain assessment will be done using Wong Baker Faces

  Pain assessment at 1st 3rd 6th 12th and 24th hour

Study Arms (2)

Normal Saline Group

PLACEBO COMPARATOR

In 30 patients who underwent Laparoscopic Cholecystectomy , 20ml of 0.9% normal saline instillation in gallbladder fossa after removal of gallbladder

Drug: Bupivacain (Postoperative); Drug: Normal (0.9%) saline

Bupivacaine Group

EXPERIMENTAL

In 30 patients who underwent Laparoscopic Cholecystectomy , 20ml of 0.25% Bupivacaine instillation in gallbladder fossa after removal of gallbladder

Drug: Bupivacain (Postoperative)

Interventions

Bupivacain (Postoperative) DRUG

20ml of 0.25% bupivacaine instillation in gallbladder fossa after removal of gallbladder in laparoscopic cholecystectomy this study used less amount of drug

Bupivacaine Group; Normal Saline Group

Normal (0.9%) saline DRUG

In 30 patients who underwent Laparoscopic Cholecystectomy , 20ml of 0.9% normal saline instillation in gallbladder fossa after removal of gallbladder.

Normal Saline Group

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients, having age 14-70 years, admitted to undergo scheduled Laparoscopic Cholecystectomy

You may not qualify if:

• Patients with history of hypersensitivity to bupivacaine Acute cholecystitis Pregnancy Lactating mothers Empyema of the gallbladder and laparoscopic converted to open surgery

Sponsors & Collaborators

• Recep Tayyip Erdogan Hospital Pakistan: lead

Study Sites (1)

Recep Tayyip Erdogan Hospital, Muzaffargarh, Pakistan

Muzaffargarh, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Gallstones; Pain, Postoperative

Interventions

Postoperative Period; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Perioperative Period; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Noman Yousaf, MBBS

  Indus Hospital & health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Noman Yousaf

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 1, 2025
• Study Start: July 11, 2024
• Primary Completion: April 20, 2025
• Study Completion: July 10, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)