Dexamethasone-Enhanced TAP Block in Lapchole | NCT07182110

Studies
Dexamethasone-Enhanced TAP Block in Lapchole

NCT07182110

Sponsor

Makassed General Hospital

Status

Active, not recruiting

Last Update Posted

Sep 19, 2025Actual

Enrollment

100Estimated

Phase

Phase 1

Conditions

Laparoscopic Cholecystectomy

Interventions

Dexamethasone enhanced TAP Block
Marcaine- 0.25%

Countries

Lebanon

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 19, 2025Actual

Primary Completion Date

Aug 30, 2026Estimated

Completion Date

Aug 30, 2026Estimated

First Submitted Date

Sep 11, 2025

First Submission Date that Met QC Criteria

Sep 11, 2025

First Posted Date

Sep 19, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2025

Last Update Posted Date

Sep 19, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohamad-Ali Barada, Anesthesia Attending, Makassed General HospitalPrincipal Investigator

Lead Sponsor

Makassed General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Marcaine	Active Comparator		Drug: Marcaine- 0.25%
Marcaine and Dexamethasone	Experimental		Drug: Dexamethasone enhanced TAP Block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone enhanced TAP Block	Drug	20 ml Marcaine containing 0.25% bupivacaine + 4 mg dexamethasone + normal saline	Marcaine and Dexamethasone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to first analgesic requirement (in hours)		within 24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult Patients
Laparoscopic Cholecystectomy Patients
Patients able to consent

Exclusion Criteria:

Patients allergic to dexamethasone
Allergic to Marcaine
Hemodynamically unstable

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Makassed General Hospital		Beirut			Lebanon

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39709396	Result	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.
38782390	Result

ID	Term
D010146	Pain
D059787	Acute Pain
D000377	Agnosia
D059390	Breakthrough Pain

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D010468	Perceptual Disorders