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Active, Not Recruiting

NCT Number: NCT07182110

Dexamethasone-Enhanced TAP Block in Lapchole

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Makassed General Hospital

Beirut, Lebanon

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Dexamethasone enhanced TAP Block

Drug

20 ml Marcaine containing 0.25% bupivacaine + 4 mg dexamethasone + normal saline

Marcaine- 0.25%

Drug

20 ml solution containing 0.25% bupivacaine + normal saline

Primary outcomes

  1. Time to first analgesic requirement (in hours)

    Time frame: within 24 hours

Sponsors and collaborators

Lead sponsor

Makassed General Hospital

Other

Registry information

Official study title

Effect of Dexamethasone-Enhanced TAP Block Mixture on Postoperative Analgesia in Laparoscopic Cholecystectomy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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