NCT02296099

Trial Liposomal Bupivacaine Following Retropubic Suburethral Sling for Stress Urinary Incontinence

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: TriHealth Inc. · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Incontinence, Stress

Interventions

Type	Name	Description
DRUG	liposomal bupivacaine	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.
DRUG	Placebo	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.

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2014-11-20
• Last updated: 2018-08-16
• Results posted: 2018-03-05

Locations

1 site across 1 country: United States