Status:
COMPLETED
Randomized Control Trial to Assess Postoperative Pain After Sling Placement
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
Stress Urinary Incontinence
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
There are many ways to perform a suprapubic approach pubovaginal sling. Some surgeons inject local pain medical into the retropubic space before placing the sling, others do not. This study is to dete...
Detailed Description
To evaluate if an injection in the retropubic space with a local acting anesthetic, Marcaine, (bupivacaine) at the time of mid-urethral sling placement will improve patients' reported post operative p...
Eligibility Criteria
Inclusion
- Any female patient, age 18 or older, who elects to have a mid-urethral sling with or without an anterior or posterior repair at the University of North Carolina Hospitals by a member of the Division of Urogynecology.
Exclusion
- Any patient with a chronic pain syndrome, a contraindication to nonsteroidal anti-inflammatory drugs (NSAIDs) such as liver disease, abnormal coagulation, esophageal disorders or peptic ulcers or where pain evaluation is unreliable because of neurological disease and those on treatment with steroids/NSAIDs/opioids prior to surgery.
- Also excluded will be any patient who is having any other reconstructive pelvic surgery concomitantly or would require the placement of a suprapubic catheter.
- Patients electing to have their surgery with regional anesthesia, such as an epidural or spinal will be excluded.
- All minors, decisional impaired people, nursing mothers and non-English speaking people will be excluded.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00746863
Start Date
January 1 2007
End Date
September 1 2009
Last Update
June 22 2010
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599