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Intraperitoneal Ropivacaine Nebulization in Gynecological Laparoscopy
NCT00433316Phase 3
Key facts
- Status
- Completed
- Start
- Feb 2007
- Primary completion
- Oct 2007
- Countries
- 1
- Sponsor
- Carmel Medical Center
- Modality
- Orthosteric Ligands
- Drugs
- ropivacaine
- Conditions
- postoperative pain
01
Overview
Phase 3, randomised, double-blind trial in postoperative pain comparing Ropivacaine Arm with Placebo Arm (2 arms). Primary endpoint: Visual Analog Scale score. Started Feb 2007; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Ropivacaine Arm
Receiving 10ml of 1% ropivacaine via nebulizer
Placebo Arm
Receiving 10ml of saline via nebulizer
03
Who it enrols
Adult female patients undergoing elective gynecologic laparoscopic surgery (salpingo-oopherectomy or ovarian cystectomy) with ASA 1-2. Excludes patients with allergy to ropivacaine, acute PID, significant arrhythmias, or those on Coumadin/Aspirin or chronic pain analgesics.
04
Endpoints
Primary
Visual Analog Scale score
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