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TAP Block vs Atracurium in Laparoscopic Gynecology

NCT03701256Phase 4

Key facts

Status: Completed
Start: Feb 2015
Primary completion: Jul 2015
Countries: 1
Sponsor: University of Tunis El Manar
Modality: Small Molecules

Drugs: bupivacaine
Conditions: gynecologic diseases

Overview

Phase 4, randomised, single-blind trial of bupivacaine in gynecologic diseases (2 arms), sponsored by University of Tunis El Manar. Primary endpoints: Abdominal compliance (Ca) and surgeon satisfaction. Started Feb 2015; status: completed.

Design

2 arms

Study design: RandomizedSingle-blind

TAP Group
Bilateral ultrasound TAP block with bupivacaine
TRAC Group
Systemic neuromuscular blockade with Atracurium

Who it enrols

Adult female patients (ASA I-III) undergoing laparoscopic gynecologic procedures, excluding those with allergies to study drugs, contraindications to regional anesthesia, or psychiatric/neurologic disorders.

Endpoints

Primary

Abdominal compliance (Ca)peroperatively every 10 minute
surgeon satisfactionperoperatively

Secondary

Heart Rate (HR)peroperatively
Mean arterial pressure (MAP)peroperatively
SpO2peroperatively
PetCO2peroperatively
Ppperoperatively
awakening time after disruption/discontinuing analgesiaperoperatively
diaphgram mouvementperoperatively
surgeons complaintperoperatively

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