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

Phase 4

Completed

Brief Summary: To determine if the injection of liposomal bupivacaine to laparoscopic port sites and rectocele repair incisions at the completion of a robotic sacrocolpopexy with concomitant rectocele repair will result in decreased postoperative pain compared to injection of placebo.

Detailed Description: In the last 20 years, laparoscopic surgery has assumed an important role in gynecological surgery. Unfortunately, patient surveys indicate there has been little improvement in the incidence and severity of postsurgical pain in the past two decades. Postoperative pain is a common complaint, occurring in 5-15% of patients and has been shown to significantly contribute to overall patient dissatisfaction. It can lead to increased consumption of opioids, with subsequent nausea, delayed bowel function, and prolonged postoperative recovery. In an attempt to address pain related complications with port-site wounds, various methods of pain control have been attempted. Currently, no standard of care exists and management is based on surgeon and anesthesiologist preferences.

This study seeks to determine if the injection of liposomal bupivacaine to laparoscopic port sites and rectocele repair incisions at the completion of a robotic sacrocolpopexy with concomitant rectocele repair will result in decreased postoperative pain compared to injection of placebo.

Recruitment & Eligibility

Inclusion Criteria

Adults 18 years of age or older
Planning for surgical treatment of POP with robotic sacrocolpopexy and rectocele repair under general anesthesia
Patient undergoing concurrent hysterectomy and/or sub-urethral sling will be included

Exclusion Criteria

Pregnant or nursing
Allergy to bupivacaine
History of drug/alcohol abuse
Severe cardiovascular, hepatic, renal disease, or neurological impairment
Long-acting opioid use 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 not undergoing general anesthesia
Patients undergoing concurrent transvaginal mesh removal, anal sphincteroplasty, or fistula repair

Arm && Interventions

Group	Intervention	Description
Placebo Arm	Placebo	Those subjects in the placebo arm will have 30 mL sterile normal saline injected. Ten mL will be injected into the perineum in the posterior vaginal area and 20 mL will be injected into the port site wounds in the abdomen (5 sites, 4 mL per incision).
Bupivacaine Arm	Bupivacaine	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).

Primary Outcome Measures

Name	Time	Method
Visual Analog Scales (VAS) for Pain at 18 Hours Postoperatively	18 hours after surgery	VAS is a validated 100 millimeter scale with no pain as 0 mm and worst pain as 100 mm. Subjects drew a vertical line on the scale corresponding to their pain level.

Secondary Outcome Measures