Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
100 participants
INTERVENTIONAL
2025-08-19
2026-08-30
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Marcaine
Marcaine- 0.25%
20 ml solution containing 0.25% bupivacaine + normal saline
Marcaine and Dexamethasone
Dexamethasone enhanced TAP Block
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
Marcaine- 0.25%
20 ml solution containing 0.25% bupivacaine + normal saline
Eligibility Criteria
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Inclusion Criteria
* Laparoscopic Cholecystectomy Patients
* Patients able to consent
Exclusion Criteria
* Allergic to Marcaine
* Hemodynamically unstable
18 Years
ALL
Yes
Sponsors
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Makassed General Hospital
OTHER
Responsible Party
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Mohamad-Ali Barada
Anesthesia Attending
Locations
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Makassed General Hospital
Beirut, , Lebanon
Countries
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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.
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.
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.
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.
Other Identifiers
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MGH-07-25037
Identifier Type: -
Identifier Source: org_study_id
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