Postoperative Pain After Instillation Of Bupivacaine During Laparoscopic Cholecystectomy

NCT ID: NCT07098429

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-11
• Study Completion Date: 2025-07-10

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

Detailed Description

Laparoscopic cholecystectomy (LC) is now widely regarded as the standard treatment for gallstones due to its advantages over open surgery, including reduced postoperative pain, shorter hospital stays, and quicker recovery. Despite these benefits, many patients still experience significant pain after surgery, attributed to factors such as port-site incisions and the residual gas used during the procedure. This study was designed to assess whether the use of bupivacaine, a local anesthetic instilled into the gallbladder bed during surgery, can help in reducing postoperative pain. The objective was to compare the pain levels in patients who received bupivacaine with those who received a placebo (normal saline) during LC.

The study included both male and female patients between the ages of 14 and 70 who were scheduled for elective laparoscopic cholecystectomy. Patients were excluded if they had a known allergy to bupivacaine, were pregnant or breastfeeding, had acute cholecystitis or gallbladder empyema, or if their surgery was converted from laparoscopic to an open procedure. A total of 60 patients were enrolled and randomly divided into two groups. Group A received 20 ml of 0.25% bupivacaine instilled into the gallbladder fossa after gallbladder removal, while Group B received 20 ml of normal saline. Both groups also received standard local anesthesia at the port sites. Following surgery, pain levels were recorded at 1, 3, 6, 12, and 24 hours using a standard pain scoring system. Additionally, the time to the first request for rescue analgesia was documented.

Participants in this study might benefit from reduced postoperative pain, decreased need for additional analgesics, and a potentially quicker recovery. The risks associated with participation were minimal, limited primarily to rare allergic reactions or local discomfort due to bupivacaine. Importantly, no narcotics were used, thereby reducing risks related to sedation or dependency.

The study was conducted at Recep Tayyip Erdogan Hospital in Muzaffargarh, Pakistan. It commenced on 19 November 2024 and concluded on 10 April 2025, with a total duration of approximately five months. The authors of the study declared that no external funding was received

Conditions

Laparoscopic Cholecystectomy; Post Operative Analgesia; Bupivacaine

Study Design

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

Study Groups

Normal Saline Group

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

Group Type: PLACEBO_COMPARATOR

Bupivacain (Postoperative)

Intervention Type: DRUG

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

Normal (0.9%) saline

Intervention Type: DRUG

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

Bupivacaine Group

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

Group Type: EXPERIMENTAL

Bupivacain (Postoperative)

Intervention Type: DRUG

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

Interventions

Bupivacain (Postoperative)

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

Intervention Type: DRUG

Normal (0.9%) saline

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

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• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Recep Tayyip Erdogan Hospital Pakistan

OTHER

Sponsor Role: lead

Responsible Party

Noman Yousaf

Noman Yousaf

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noman Yousaf, MBBS

Role: PRINCIPAL_INVESTIGATOR

Indus Hospital & health Network

Locations

Recep Tayyip Erdogan Hospital, Muzaffargarh, Pakistan

Muzaffargarh, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

IHHN _IRB_2024_04_002

Identifier Type: -

Identifier Source: org_study_id