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

Study Overview
=================
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.

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

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Liposomal bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Liposomal bupivacaine<br>Subjects in this arm will received the drug - liposomal bupivacaine 30 ml. | Drug: Liposomal bupivacaine<br>* 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.<br>* Other names: Exparel;|
| Placebo Comparator: Placebo<br>Subjects in this arm will received the placebo - normal saline 30 mL. | Drug: Placebo<br>* 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.<br>* 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 |