Status:
COMPLETED
Trial Liposomal Bupivacaine Following Retropubic Suburethral Sling for Stress Urinary Incontinence
Lead Sponsor:
TriHealth Inc.
Conditions:
Urinary Incontinence, Stress
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to determine if the administration of liposomal bupivacaine at the completion of a suburethral sling procedure will result in decreased postoperative pain compared to no in...
Detailed Description
The purpose of the study is to determine if the administration of liposomal bupivacaine at the completion of a suburethral sling procedure will result in decreased postoperative pain compared to no in...
Eligibility Criteria
Inclusion
- Adults greater than 18 years of age
- Planning for outpatient surgical treatment of stress urinary incontinence with placement of a retropubic suburethral sling under general anesthesia
Exclusion
- Pregnant or nursing
- Allergy to bupivacaine
- History of drug/alcohol abuse
- Severe cardiovascular, hepatic, renal disease, or neurological impairment
- Long-acting opioid within 3 days or any opioid use within 24 hours before surgery
- Contraindication to: acetaminophen, oxycodone, and/or non-steroidal anti-inflammatory drugs (NSAID)
- Administration of an investigational drug within 30 days before study
- Chronic pain syndromes
- Daily NSAID/opioid use
- Patients having concomitant procedures or not undergoing general anesthesia
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT02296099
Start Date
November 1 2014
End Date
August 1 2016
Last Update
August 16 2018
Active Locations (1)
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1
Cincinnati Urogynecology Associates
Cincinnati, Ohio, United States, 45220