Trial Liposomal Bupivacaine Following Retropubic Suburethral Sling for Stress Urinary Incontinence

Completed · Phase 4 · Has a placebo group

Conditions studied: Urinary Incontinence, Stress

In brief

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.

Key facts

Study ID

NCT02296099

Run by

TriHealth Inc.

People needed

114

Starts

2014-11-01

Expected to finish

2016-08-01

Last updated by the study team

2018-08-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cincinnati Urogynecology Associates — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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