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Intraperitoneal Saline vs Ropivacaine for Pain After Laparoscopic Cholecystectomy
NCT02819544Phase 3
Key facts
- Status
- Withdrawn
- Start
- Sep 2016
- Primary completion
- May 2017
- Countries
- 1
- Sponsor
- CHU Amiens-Picardie
- Drugs
- sodium chloride
- Conditions
- postoperative pain
01
Overview
Phase 3, randomised, single-blind trial of sodium chloride in postoperative pain (2 arms), sponsored by CHU Amiens-Picardie. Primary endpoint: Pain measured by visual analog scale at Day 6. Planned start Sep 2016; status: withdrawn.
02
Design
2 arms- Study design
- RandomizedSingle-blind
Ropivacaine
Ropivacaine 7.5 mg/mL administration
Sodium chloride
NaCl 0.9% administration
03
Who it enrols
Adult patients (18-80 years) with biliary pathology requiring laparoscopic cholecystectomy, eligible for outpatient care, without chronic pain or addiction to painkillers.
04
Endpoints
Primary
Pain measured by visual analog scale
Secondary
Global pain measured by Brief Pain Inventory scale
Analgesics use
Global morbidity
Specific complications for each treatment
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