Dexamethasone-Enhanced TAP Block in Lapchole

NCT07182110 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: MGH-07-25037
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Laparoscopic Cholecystectomy

Keywords

Transversus Abdominis; Nerve Block; Dexamethasone; Pain; Acute Pain; Pain Management; Breakthrough Pain; Analgesics, Opioid; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Time to first analgesic requirement (in hours)

  within 24 hours

Study Arms (2)

Marcaine

ACTIVE COMPARATOR

Drug: Marcaine- 0.25%

Marcaine and Dexamethasone

EXPERIMENTAL

Drug: Dexamethasone enhanced TAP Block

Interventions

Dexamethasone enhanced TAP Block DRUG

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

Marcaine and Dexamethasone

Marcaine- 0.25% DRUG

20 ml solution containing 0.25% bupivacaine + normal saline

Marcaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Makassed General Hospital: lead

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

Location

Related Publications (4)

• Ghani SA, Hussain HU, Wahid MA, Majeed N, Burney S, Tanveer A, Asghar MS. Laparoscopic-assisted versus ultrasound-guided transversus abdominis plane block for laparoscopic cholecystectomy: a systematic review and meta-analysis. BMC Surg. 2024 Dec 21;24(1):400. doi: 10.1186/s12893-024-02706-7.

  PMID: 39709396 BACKGROUND

• Uzunay NT, Mingir T, Erginoz E, Karakas DO, Kose E. Comparison of laparoscopic-guided versus ultrasound-guided TAP block in laparoscopic cholecystectomy. Cir Cir. 2024;92(2):174-180. doi: 10.24875/CIRU.23000394.

  PMID: 38782390 BACKGROUND

• Taheri P, Moinfar Z, Varpaei HA. Comparison of the Stress Responses After TAP Block and Epidural Anesthesia in Patients Undergoing Elective Laparoscopic Cholecystectomy Under General Anesthesia: Randomized Clinical Trial. Clin J Pain. 2023 Jul 1;39(7):319-325. doi: 10.1097/AJP.0000000000001117.

  PMID: 37083674 BACKGROUND

• Nair P, Behera CR, Patra RK, Shekar N, Rao LS, Pujari P, Panda B, Mishra A. Efficacy and Cost-Effectiveness of Laparoscopic Transversus Abdominis Plane (TAP) Block in Laparoscopic Cholecystectomy: A Comparison With the Non-TAP Group. Cureus. 2022 Nov 30;14(11):e32038. doi: 10.7759/cureus.32038. eCollection 2022 Nov.

  PMID: 36600856 BACKGROUND

MeSH Terms

Conditions

Pain; Acute Pain; Agnosia; Breakthrough Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia Attending

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 19, 2025
• Study Start: August 19, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)