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

Phase 4TerminatedNCT02591888

TriHealth Inc.18 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pain

Interventions

PlaceboDRUG

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.

Liposomal bupivacaineDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

TriHealth

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: 4 hours after being discharged home

Secondary Outcomes

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.

Time frame: At 1 and 2 weeks postoperatively

Data from ClinicalTrials.gov

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