Improvement of Pain Following Robotic Sacrocolpopexy and Rectocele Repair for Pelvic Organ Prolapse

PHASE4CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

August 31, 2016

Study Completion Date

August 31, 2016

Conditions
Pelvic Organ Prolapse
Interventions
DRUG

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 liposomal bupivacaine arm will have 30mL dilutional volume injected. Ten mL will be injected into the perineum in the posterior vaginal area and 20 mL will be injected the port site wounds in the abdomen (5 sites, 4 ml per incision).

DRUG

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 30mL total volume injected. Ten mL will be injected into the perineum in the posterior vaginal area and 20 mL will be injected the port site wounds in the abdomen (5 sites, 4 ml per incision).

Trial Locations (1)

45220

Cincinnati Urogynecology Associates, Cincinnati

All Listed Sponsors
lead

TriHealth Inc.

OTHER

NCT02449915 - Improvement of Pain Following Robotic Sacrocolpopexy and Rectocele Repair for Pelvic Organ Prolapse | Biotech Hunter | Biotech Hunter