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Pre-Operative Gabapentin in Gynecologic Laparoscopy
NCT02359110Phase 4
Key facts
- Status
- Completed
- Start
- Jun 2015
- Primary completion
- Jan 2017
- Countries
- 1
- Sponsor
- Penn State Health Milton S. Hershey Medical Center
- Modality
- Small Molecules
- Drugs
- gabapentin
- Conditions
- postoperative pain
01
Overview
Phase 4, randomised, double-blind trial in postoperative pain comparing Gabapentin with Placebo (2 arms). Primary endpoint: Numerical Rating Scale. Started Jun 2015; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Gabapentin
Gabapentin 300mg tab less than 1 hour before surgery
Placebo
Methylcellulose based placebo tab less than 1 hour before surgery
03
Who it enrols
Adult females undergoing laparoscopic or robotic assisted procedures for benign gynecologic indications, excluding those with chronic gabapentin use or pregnancy.
04
Endpoints
Primary
Numerical Rating Scale
Secondary
Visual Analog Scale
Total Morphine Consumption
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