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

The Impact of Liposomal Bupivacaine Administered Following Placement of a Transobturator Suburethral Sling for Stress Urinary Incontinence: A Randomized Placebo-controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Pain
• Intervention / Treatment: Drug: Liposomal bupivacaine; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • TriHealth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Liposomal bupivacaine; Subjects in this arm will received the drug - liposomal bupivacaine 30 ml.	Drug: Liposomal bupivacaine; At the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure), those subjects in the placebo arm will have the 30ml of dilutional liposomal bupivacaine injected.; Other Names: Exparel
Placebo Comparator: Placebo; Subjects in this arm will received the placebo - normal saline 30 mL.	Drug: Placebo; At the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure), those subjects in the placebo arm will have the 30ml of normal saline injected.; Other Names: Normal Saline

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Likert scale to rate their level of satisfaction with their postoperative pain control.	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.	At 1 and 2 weeks postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS to rate their level of satisfaction with their postoperative pain control.	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.	At 1 & 2 weeks postoperatively

Collaborators and Investigators

• Sponsor: TriHealth Inc.
• Investigators: Principal Investigator: Catrina C Crisp, MD, TriHealth Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: February 26, 2015
• First Submitted That Met QC Criteria: October 29, 2015
• First Posted (Estimate): October 30, 2015

Study Record Updates

• Last Update Posted (Actual): July 23, 2018
• Last Update Submitted That Met QC Criteria: July 19, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 14-081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO