Clinical trial NCT02296099: Trial Liposomal Bupivacaine Following Retropubic Suburethral Sling for Stress Urinary Incontinence
Official title: The Impact of Liposomal Bupivacaine Administered Following Placement of a Retropubic Suburethral Sling for Stress Urinary Incontinence: a Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Incontinence, Stress
Keywords: retropubic suburethral sling
stress urinary incontinence
liposomal bupivacaine
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain in the Morning
timeFrame: Day 1
Secondary outcomes:
measure: Pain Upon Discharge From Post-anesthesia Care Unit (PACU)
timeFrame: 1 day
measure: Pain Upon Discharge From Same Day Surgery
timeFrame: 1 day
measure: Pain at Four Hours After Discharge Home
timeFrame: 1 day, 4 hours after discharge from Same Day Surgery
measure: Total Narcotic Consumption
timeFrame: Day 1 - 3
measure: Number of Participants Reporting 'Very Satisfied' at the 1 Week Postoperative Visit
timeFrame: 1 week
Other outcomes:
measure: Number of Participants Reporting 'Very Satisfied' at the 2 Week Postoperative Visit
timeFrame: 2 weeks
measure: Pain at Bedtime (Current Level of Pain)
timeFrame: Day 1
measure: Pain at Bedtime (Most Intense Pain)
timeFrame: Day 1
measure: Pain at Bedtime (Average Pain)
timeFrame: Day 1
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Urogynecology Associates
state: Ohio
Study officials:
affiliation: TriHealth Inc.
name: Catrina Crisp, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: