NCT01916473CompletedNot Applicable
Epidural Versus Continuous Wound Ropivacaine Infusion: Effect on Acute and Chronic Pain After Myomectomy or Total Abdominal Hysterectomy. A Randomized Controlled Trial
University of Athens2 sites in 1 country80 target enrollmentStarted: April 1, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Postoperative morphine consumption
Study Overview
Brief Summary
Study Hypothesis: The analgesic requirements and pain scores postoperatively differ between the epidural and continuous wound infusion techniques.
Detailed Description
The analgesic requirements and pain scores postoperatively differ between the epidural and continuous wound infusion techniques, in patients undergoing myomectomy or hysterectomy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients ASA I-II scheduled for abdominal hysterectomy or myomectomy -
Exclusion Criteria
- •Age older than 60 and younger than 25 years, body weight exceeding the 30% of the ideal, consumption of analgesics, sedatives, anxiolytics, antidepressants, calcium channel blockers, CNS disease or insulin dependent diabetes
Outcomes
Primary Outcomes
Postoperative morphine consumption
Time Frame: 6 months postoperatively
Secondary Outcomes
- pain scores(6 months postoperatively)
Investigators
Argyro Fassoulaki
Professor of Anesthesiology
University of Athens
Study Sites (2)
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