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Active Not RecruitingNCT07182110

Dexamethasone-Enhanced TAP Block in Lapchole

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

Status
Active Not Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Makassed General Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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

Conditions

Interventions

TypeNameDescription
DRUGDexamethasone enhanced TAP Block20 ml Marcaine containing 0.25% bupivacaine + 4 mg dexamethasone + normal saline
DRUGMarcaine- 0.25%20 ml solution containing 0.25% bupivacaine + normal saline

Timeline

Start date
2025-08-19
Primary completion
2026-08-30
Completion
2026-08-30
First posted
2025-09-19
Last updated
2025-09-19

Locations

1 site across 1 country: Lebanon

Source: ClinicalTrials.gov record NCT07182110. Inclusion in this directory is not an endorsement.