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

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT02591888

Run by

TriHealth Inc.

People needed

18

Starts

2015-02-01

Expected to finish

2017-12-01

Last updated by the study team

2018-07-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Adults > 18 years of age
• Planning for outpatient surgical treatment of SUI with placement of a transobturator 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
• 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.

Where it is running

• TriHealth — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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