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Trial Liposomal Bupivacaine Following Retropubic Suburethral Sling for Stress Urinary Incontinence

NCT02296099 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2018-08-16

Study results available
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Summary

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.

Conditions

  • Urinary Incontinence, Stress

Interventions

DRUG

liposomal bupivacaine

Liposomal bupivacaine 20 mL diluted with 10 mL normal saline. Ten mL of solution to be injected into the vaginal epithelium in the mid-urethral area and 10 mL injected into each of the trocar paths through the suprapubic incisions bilaterally.

DRUG

Placebo

Normal saline 30 mL total injected. Ten mL injected into the vaginal epithelium in the mid-urethral area and 10 mL will be injected into each of the trocar paths through the suprapubic incisions bilaterally.

Sponsors & Collaborators

  • TriHealth Inc.

    lead OTHER

Principal Investigators

  • Catrina Crisp, MD, MSc · TriHealth Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02296099 on ClinicalTrials.gov