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

Phase 4

Terminated

• Conditions: Pain
• Interventions: Drug: Liposomal bupivacaine; Drug: Placebo

• Registration Number: NCT02591888
• Lead Sponsor: TriHealth Inc.

Brief 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.

Detailed Description

The investigators aim to evaluate the use of liposomal bupivacaine to reduce postoperative pain from placement of transobturator slings for the treatment of stress urinary incontinence.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-26
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-10-30
• Primary Completion: 2017-03
• Study Completion: 2017-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-07-19
• Last Update Posted: 2018-07-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liposomal bupivacaine	Liposomal bupivacaine	Subjects in this arm will received the drug - liposomal bupivacaine 30 ml.
Placebo	Placebo	Subjects in this arm will received the placebo - normal saline 30 mL.

Primary Outcome Measures

Name	Time	Method
Visual analog scale (VAS)	4 hours after being discharged home	To determine if liposomal bupivacaine administered at the completion of a transobturator suburethral sling will result in decreased postoperative pain compared to placebo.

Secondary Outcome Measures

Name	Time	Method
Likert scale to rate their level of satisfaction with their postoperative pain control.	At 1 and 2 weeks postoperatively	To assess the amount of oral narcotic required for pain control following administration of liposomal bupivacaine or placebo at the completion of a transobturator sling procedure.

Trial Locations

Locations (1)

TriHealth; 🇺🇸 Cincinnati, Ohio, United States