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Active, not recruitingNCT07182110Updated Sep 19, 2025

Dexamethasone-Enhanced TAP Block in Lapchole

A Phase 1 interventional study of Dexamethasone enhanced TAP Block and Marcaine- 0.25% in Laparoscopic Cholecystectomy, sponsored by Makassed General Hospital. Active, not recruiting at 1 site in Lebanon. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-19.

Sponsored by Makassed General Hospital · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Laparoscopic Cholecystectomy

Keywords

  • Transversus Abdominis
  • Nerve Block
  • Dexamethasone
  • Pain
  • Acute Pain
  • Pain Management
  • Breakthrough Pain
  • Analgesics, Opioid
  • Anesthesia
03

In context

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's planned enrollment of 100 is above the median of 66 across 8,493 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Makassed General Hospital is the lead sponsor of 39 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients allergic to dexamethasone
  • Allergic to Marcaine
  • Hemodynamically unstable
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Marcaine

    Drug: Marcaine- 0.25%

  • Experimental
    Marcaine and Dexamethasone

    Drug: Dexamethasone enhanced TAP Block

Interventions

  • DrugDexamethasone enhanced TAP Block

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

  • 20 ml solution containing 0.25% bupivacaine + normal saline

06

What researchers measure

Primary outcomes

  1. Time to first analgesic requirement (in hours)

    Time frame: within 24 hours

07

Study locations

1 site
  • Makassed General Hospital
    Beirut, Lebanon
08

References and documents

Publications

  • 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. PubMed 39709396 ↗
  • 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. PubMed 38782390 ↗
  • 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. PubMed 37083674 ↗
  • 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. PubMed 36600856 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for Aug 2026, 12 months after the start.

Of 117 non-industry phase 1 interventional studies under Pain, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 45. This study's planned 12 months is below that.

Counting every sponsor, half of 221 studies reached it within 9 months; a quarter within 3 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2025
First posted
Sep 19, 2025
StartActual
Aug 19, 2025
Primary completionEst.
Aug 30, 2026
CompletionEst.
Aug 30, 2026
Last update
Sep 19, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07182110
Lead sponsor
Makassed General Hospital
Responsible party
Mohamad-Ali Barada (Anesthesia Attending, Makassed General Hospital) — Principal investigator
First posted
Sep 19, 2025
Start date
Aug 19, 2025
Primary completion
Aug 30, 2026 (estimated)
Completion
Aug 30, 2026 (estimated)
Last update
Sep 19, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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