Dexamethasone-Enhanced TAP Block in Lapchole

NCT ID: NCT07182110

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-19

Study Completion Date

2026-08-30

Brief Summary

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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

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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

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Laparoscopic Cholecystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Marcaine

Group Type ACTIVE_COMPARATOR

Marcaine- 0.25%

Intervention Type DRUG

20 ml solution containing 0.25% bupivacaine + normal saline

Marcaine and Dexamethasone

Group Type EXPERIMENTAL

Dexamethasone enhanced TAP Block

Intervention Type DRUG

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

Interventions

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Dexamethasone enhanced TAP Block

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

Intervention Type DRUG

Marcaine- 0.25%

20 ml solution containing 0.25% bupivacaine + normal saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult Patients
* Laparoscopic Cholecystectomy Patients
* Patients able to consent

Exclusion Criteria

* Patients allergic to dexamethasone
* Allergic to Marcaine
* Hemodynamically unstable
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Makassed General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mohamad-Ali Barada

Anesthesia Attending

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Makassed General Hospital

Beirut, , Lebanon

Site Status

Countries

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Lebanon

References

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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.

Reference Type BACKGROUND
PMID: 39709396 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38782390 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37083674 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36600856 (View on PubMed)

Other Identifiers

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MGH-07-25037

Identifier Type: -

Identifier Source: org_study_id

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