Clinical trial NCT02449915: Improvement of Pain Following Robotic Sacrocolpopexy and Rectocele Repair for Pelvic Organ Prolapse
Official title: Does Liposomal Bupivacaine Improve Pain Following Robotic Sacrocolpopexy and Rectocele Repair for Pelvic Organ Prolapse? A Randomized Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pelvic Organ Prolapse
Keywords: sacrocolpopexy
rectocele repair
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2015-05-20
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scales (VAS) for Pain at 18 Hours Postoperatively
timeFrame: 18 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Urogynecology Associates
state: Ohio
Study officials:
affiliation: Cincinnati Urogynocolgy Associates
name: Rachel Pauls, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yeung J, Crisp CC, Mazloomdoost D, Kleeman SD, Pauls RN. Liposomal Bupivacaine During Robotic Colpopexy and Posterior Repair: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jan;131(1):39-46. doi: 10.1097/AOG.0000000000002375.