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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07650760
Enrollment
106
Registered
2026-06-16
Start date
2026-07-01
Completion date
2026-12-01
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

laparoscopic cholecystectomy

Brief summary

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.

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.

Interventions

DRUGBupivacain

In group A intraperitoneal bupivacaine is used for pain relief

DRUGSaline (0.9% NaCl)

In group B intraperitoneal saline is used for pain relief as placebo.

Sponsors

Wah Medical college , POF hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

This study was conducted as a double-blinded randomized controlled trial. In this design, the outcome assessor (observer) was blinded to the group allocation, while the operating surgeon was also not aware of the intervention being performed.Blinding was achieved by ensuring that the trained observer responsible for recording postoperative outcomes, including post operative pain, did not know whether bupivacaine or normal saline was used during the procedure. This helped to minimize observer bias in outcome measurement

Intervention model description

This study is a prospective, parallel-group randomized controlled trial (RCT) designed to compare two different techniques for achieving post operative pain relief following laparoscopic cholecystectomy.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Post operative pain reliefFrom the completion of the procedure til one hour after surgeryThe study primarily aimed to compare post operative pain relief following intraperitoneal irrigation of bupivacaine vs normal saline.

Countries

Pakistan

Contacts

CONTACTMuhammad Asad Janjua, MBBS
asad24871@gmail.com00923351589093

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026