Compare Intraperitoneal Instillation of Bupivacaine+dexmedetomidine Versus Bupivacaine+dexamethasone on Postoperative Pain After Lap Cholecystectomy

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: bupivacaine with dexamethasone; Drug: bupivacaine with dexmedetomidine

• Registration Number: NCT06535256
• Lead Sponsor: Aswan University Hospital

Brief Summary

Comparison of intraperitoneal instillation of bupivacaine with dexmedetomidine versus bupivacaine with dexamethasone on postoperative pain after laparoscopic cholecystectomy

Detailed Description

Laparoscopy has become the preferred mode for many diagnostic and operative procedures. It has the advantage better cosmetic results, faster recovery, short post-operative hospital stays, and early resumption of normal activities. Post-laparoscopic pain results from stretching of the intra-abdominal cavity, peritoneal inflammation, and diaphragmatic irritation caused by residual carbon-dioxide in the peritoneal cavity is very annoying to the patients.

Although the severity of pain after a laparoscopic procedure is less compared to laparotomy, but it is acute and can lead to increased analgesic requirements and prolonged hospital stays.

Several studies have evaluated post-laparoscopic pain relief methods such as intravenous analgesics analgesic patches, steroids, and intra-peritoneal instillation of local anaesthetics alone or with additives.

Study Timeline

• Study Start: 2024-06-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-25
• Study First Submitted QC: 2024-07-31
• Study First Posted: 2024-08-02
• Primary Completion: 2024-11-10
• Study Completion: 2024-12-01
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bupivacaine with dexamethasone	bupivacaine with dexamethasone	40 mL of 0.25% bupivacaine + 16 mg dexamethasone with 5 ml normal saline).
bupivacaine with dexmedetomidine	bupivacaine with dexmedetomidine	40 mL of 0.25% bupivacaine + dexmedetomidine 1 μg/kg with normal saline 5 ml).

Primary Outcome Measures

Name	Time	Method
incidence and severity of postoperative pain for 24 hours	severity of postoperative pain measured at 1, 2, 4, 8, 16, and 24 hours. postoperatively, using Visual Analogue Scale	using VAS pain score

Trial Locations

Locations (2)

Zaher; 🇪🇬 Cairo, Egypt

Zaher; 🇪🇬 Cairo, Egypt