Dexamethasone-Enhanced TAP Block in Lapchole

Not Applicable

Active, not recruiting

• Conditions: Laparoscopic Cholecystectomy
• Interventions: Drug: Marcaine- 0.25%; Drug: Dexamethasone enhanced TAP Block

• Registration Number: NCT07182110
• Lead Sponsor: Makassed General Hospital

Brief Summary

The transversus abdominis plane (TAP) block is widely used as part of analgesia for abdominal surgeries such as laparoscopic cholecystectomy. While bupivacaine is commonly used for TAP blocks with reported success. Dexamethasone is often used as an adjuvant in prolonging duration of blocks; however, data on its efficacy in enhancing TAP blocks in laparoscopic cholecystectomy remain limited. This study aims to assess whether adding dexamethasone to bupivacaine in a TAP block improves postoperative pain control and reduces opioid consumption

Detailed Description

Hypothesis Patients receiving a dexamethasone-enhanced TAP block will have a longer duration of analgesia, lower postoperative pain scores, and reduced opioid requirements compared to patients receiving local anesthetic alone.

Objectives

* Primary Objective:

* To evaluate the time to first postoperative analgesic request.

* Secondary Objectives:

* To assess postoperative pain using the Visual Analog Scale (VAS).

* To evaluate the incidence of postoperative nausea and vomiting (PONV).

* To compare total postoperative analgesic consumption.

* To assess the need for rescue analgesia.

Methods Study Design

* Prospective, randomized, double-blind clinical trial. Study Population

* Adult patients (age ≥18), ASA physical status I to III, planned for elective laparoscopic cholecystectomy. Interventions

* All patients will undergo standard general anesthesia.

* TAP block will be performed pre-induction bilaterally by an experienced anesthesiologist blinded to the injectate.

* Patients will be randomized into two groups:

* Group A (Control): 20 ml solution containing 0.25% bupivacaine + normal saline

* Group B (Intervention): 20 ml solution containing 0.25% bupivacaine + 4 mg dexamethasone + normal saline

All patients will receive standard postoperative care, including paracetamol and antiemetics

Study Timeline

• Study Start: 2025-08-19
• Status Verified: 2025-09
• Study First Submitted: 2025-09-11
• Study First Submitted QC: 2025-09-11
• Last Update Submitted: 2025-09-11
• Study First Posted: 2025-09-19
• Last Update Posted: 2025-09-19
• Primary Completion: 2026-08-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

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

Inclusion Criteria

• Adult Patients
• Laparoscopic Cholecystectomy Patients
• Patients able to consent

Exclusion Criteria

• Patients allergic to dexamethasone
• Allergic to Marcaine
• Hemodynamically unstable

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Marcaine	Marcaine- 0.25%	-
Marcaine and Dexamethasone	Dexamethasone enhanced TAP Block	-

Primary Outcome Measures

Name	Time	Method
Time to first analgesic requirement (in hours)	within 24 hours

Trial Locations

Locations (1)

Makassed General Hospital; 🇱🇧 Beirut, Lebanon