Comparison of Intraperitoneal Bupivacaine and Saline Irrigation for Pain Relief After Laparoscopic Cholecystectomy

June 13, 2026 updated by: Wah Medical college , POF hospital

Comparison of Intraperitoneal Bupivacaine and Normal Saline Irrigation for Postoperative Pain Relief After Laparoscopic Cholecystectomy

This randomized clinical trial compared intraperitoneal irrigation of bupivacaine(a local anesthetic) vs a control group receiving normal saline for relief of post operative pain following laparoscopic gallbladder surgery. A total of 106 patients divided into two equal groups, with one group receiving bupivacaine and the other treated using normal saline(control).Previous studies on the subject found that bupivacaine significantly reduced postoperative pain. Although conventional intravenous analgesics remain widely used, bupivacaine may be a better option, especially in difficult surgical cases.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized clinical trial was conducted to compare the effectiveness of intraperitoneal bupivacaine and normal saline for relief of post operative pain following laparoscopic cholecystectomy. A total of 106 patients undergoing elective laparoscopic gallbladder surgery were enrolled and randomly assigned into two equal groups. Non-probability consecutive sampling technique will be used to recruit patients.Patients with clinical findings of choledocholithiasis/pancreatitis/cholecystitis, who need intraoperative conversion to an open procedure, are pregnant or lactating, do not have the capacity to express pain, or have any contraindication to the drugs under study, will be excluded.In Group A, the patients received intraperitoneal irrigation of bupivacaine , while in Group B, only normal saline was used. The standard procedure of laparoscopic cholecystectomy will be similar in both groups, except for the difference that group A patients will undergo intraperitoneal instillation of 500ml normal saline solution, whereas those allocated into group B will have peritoneal irrigation using 20ml of 10% bupivacaine solution diluted in 480ml of normal saline to make a 500ml irrigation solution at the time of peritoneal closure. To ensure double blinding, the primary surgeon and patient will be blinded to the type of solution used. The time of extubation will be noted, which will be used to determine the duration of analgesia. Patients will be followed up for VAS scores at time intervals of 1, 2, 4, 6, 12, and 24 hours postoperatively. When the patient complains of pain, intravenous tramadol of 37.5mg mixed with an antiemetic will be administered.To reduce confounding, all procedures are done by the same consultant surgeon; no additional postoperative analgesic advised, and a blinded surgeon will evaluate the patient for the pain scores at these intervals, with due recording of the dosages of rescue analgesics and duration of analgesia.Past literature has provided some insight into the efficacy of bupivacaine in reducing postoperative pain, but existing evidence is not enough to establish clinical practice guidelines. Our study has the rationale of strengthening the existing body of evidence by extending the research.

Study Type

Interventional

Enrollment (Estimated)

106

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab Province
      • Wāh, Punjab Province, Pakistan, 47040
        • Recruiting
        • Wah Medical College, POF Hospital Wah cantt Wāh
        • Contact:
        • Principal Investigator:
          • Muhammad asad Janjua, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • Adult consented patients of any gender aged 18 to 60 years Fit to undergo elective laparoscopic cholecystectomy

Exclusion Criteria:

  • • Patients who had developed choledocholithiasis or pancreatitis pre-operatively

    • Where conversion to open cholecystectomy is needed intraoperatively
    • Pregnant or lactating
    • Inability to express pain appropriately, like in psychiatric disorders
    • With any contraindication to the use of bupivacaine or normal saline, e.g., hypersensitivity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental : group A: bupivacaine
Group A is the arm where patients have received intraperitoneal bupivacaine during laparoscopic gallbladder surgery, and their post operative pain is compared .
Drug: Bupivacain
In group A intraperitoneal bupivacaine is used for pain relief
Other Names:
  • Group A
Placebo Comparator: Placebo : group B: saline
Placebo : group B: saline Group B is the arm where patients have received only intraperitoneal normal saline .
Drug: Saline (0.9% NaCl)
In group B intraperitoneal saline is used for pain relief as placebo.
Other Names:
  • Group B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative pain relief
Time Frame: From the completion of the procedure til one hour after surgery
The study primarily aimed to compare post operative pain relief following intraperitoneal irrigation of bupivacaine vs normal saline.
From the completion of the procedure til one hour after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wah Medical college , POF hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 6, 2026

First Submitted That Met QC Criteria

June 13, 2026

First Posted (Actual)

June 16, 2026

Study Record Updates

Last Update Posted (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 13, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WMC/ERC/IRB/134

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

1 year after publication of article in journal

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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