Trial Liposomal Bupivacaine Following Retropubic Suburethral Sling for Stress Urinary Incontinence

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: Female

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 injection.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TriHealth Inc.
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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