Dexamethasone-Enhanced TAP Block in Lapchole

Makassed General Hospital

Status and phase: Active, not recruiting; Phase 1

Conditions: Laparoscopic Cholecystectomy

Treatments: Drug: Marcaine- 0.25%; Drug: Dexamethasone enhanced TAP Block

Study type: Interventional

Funder types: Other

Identifiers

NCT07182110

MGH-07-25037

Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Marcaine

Active Comparator group

Treatment:

Drug: Marcaine- 0.25%

Marcaine and Dexamethasone

Experimental group

Treatment:

Drug: Dexamethasone enhanced TAP Block