Impact of Liposomal Bupivacaine Administered Following Placement of a Transobturator Suburethral Sling

• Status: Terminated
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Liposomal bupivacaine or placebo will be administered at the end of a transobturator midurethral sling to determine if there is a difference in a patient's perceived postoperative pain.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: TriHealth Inc.
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• Adults > 18 years of age

• Planning for outpatient surgical treatment of SUI with placement of a transobturator 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

• 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

• Patients who require a concomitant anterior repair or urethrocele repair will not be excluded as this requires the same dissection in the anterior vaginal wall.