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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Liposomal bupivacaine

Subjects in this arm will received the drug - liposomal bupivacaine 30 ml.

Group Type ACTIVE_COMPARATOR

Liposomal bupivacaine

Intervention Type DRUG

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.

Placebo

Subjects in this arm will received the placebo - normal saline 30 mL.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Normal Saline Exparel

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes