Trial Liposomal Bupivacaine Following Retropubic Suburethral Sling for Stress Urinary Incontinence

Study Overview
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Brief Summary
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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.

Detailed Description
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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. The hypothesis is that administration of liposomal bupivacaine at the completion of retropubic suburethral sling procedure will result in decreased postoperative pain compared to no injection. Although multiple routes for sling placement exist, no difference in pain has been found when comparing obturator verses retropubic suburethral sling. Previous trials have investigated varying formulations of injections along the sling pathway in order to reduce complications such as pain and voiding dysfunction. Local anesthesia along the trocar pathway has shown some improvements in pain. Other techniques, however, have varying results. In 2011, the FDA approved liposomal bupivacaine as a single dose wound infiltration for treatment of postoperative pain following hemorrhoidectomy and bunionectomy. Initial studies demonstrated decreased pain compared to placebo, prolonged release in a bimodal distribution, and greater sensory than motor blockade. Additionally, postoperative benefits such as decreased overall pain, decreased opioid use, and increased time to opioid need were observed. Liposomal bupivacaine may also have the advantage of reducing hospital stays and decreasing overall hospital costs. The side effect profile has similar or improved rates of adverse events compared to traditional bupivacaine, a favorable cardiac profile, and no increased risk of poor wound healing. With such promise, we aim to evaluate the use of liposomal bupivacaine to reduce postoperative pain for the placement of slings to treat stress urinary incontinence. The study will be a blinded randomized controlled trial. Patients randomized to receive liposomal bupivicaine, the standard 20ml vial will be diluted with 1 Oml of saline to a reconstituted volume of 30 ml. Those in the control group will receive 30ml of normal saline injected in the same fashion as the study arm.

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

Conditions
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Urinary Incontinence, Stress

Intervention / Treatment
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* Drug: liposomal bupivacaine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults greater than 18 years of age Planning for outpatient surgical treatment of stress urinary incontinence with placement of a retropubic 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, and/or 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposomal Bupivacaine<br>The placement of the retropublic sling will be placed in routine fashion under general anesthesia. If randomized to liposomal bupivacaine, the standard 20 milliliter (ml) vial (266mg dose) will be diluted with 10ml of preservative-free, sterile normal saline (0.9%) for injection to a reconstituted volume of 30ml. At the completion of the procedure, and at least 20 minutes after the injection of 30ml lidocaine with epinephrine (routine for the surgical procedure), those subjects in the liposomal bupivacaine arm will have the 30ml dilutional volume injected. 10ml will be injected into the vaginal epithelium in the mid-urethral area and 10ml will be injected into each of the trocar paths through the suprapubic incisions bilaterally. An aspiration and moving needle technique will be employed. | Drug: liposomal bupivacaine<br>* 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.<br>* Other names: Exparel;|
| Placebo Comparator: Saline Placebo<br>The placement of the retropublic sling will be placed in routine fashion under general anesthesia. At the completion of the procedure, and at least 20 minutes after the injection of 30ml lidocaine with epinephrine (routine for the surgical procedure), those subjects in the saline placebo arm will receive 30ml normal saline injected. 10ml will be injected into the vaginal epithelium in the mid-urethral area and 10ml will be injected into each of the trocar paths through the suprapubic incisions bilaterally. An aspiration and moving needle technique will be employed. | Drug: Placebo<br>* 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.<br>* Other names: Normal Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain in the Morning | A visual analog scale (VAS) will be used to have the patient rate her pain in the morning of postoperative day one. The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Upon Discharge From Post-anesthesia Care Unit (PACU) | A visual analog scale (VAS) will be used to have the patient rate her pain upon discharge from the PACU. The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported. | 1 day | 
| Pain Upon Discharge From Same Day Surgery | A visual analog scale (VAS) will be used to have the patient rate her pain upon discharge from same day surgery. The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported. | 1 day | 
| Pain at Four Hours After Discharge Home | A visual analog scale (VAS) will be used to have the patient rate her pain four hours after being discharged home. The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported. | 1 day, 4 hours after discharge from Same Day Surgery | 
| Total Narcotic Consumption | Cumulative consumption postoperative days 1 - 3 | Day 1 - 3 | 
| Number of Participants Reporting 'Very Satisfied' at the 1 Week Postoperative Visit | A likert type scale will be used to have the patient rate their satisfaction with pain control at their one week postoperative visit. Count information for those who were very satisfied were provided. | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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retropubic suburethral sling, stress urinary incontinence, liposomal bupivacaine