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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Does Liposomal Bupivacaine Improve Pain Following Robotic Sacrocolpopexy and Rectocele Repair for Pelvic Organ Prolapse? A Randomized Placebo Controlled Trial

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupivacaine Arm<br>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: Bupivacaine<br>* 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).<br>* Other names: Exparel;|
| Placebo Comparator: Placebo Arm<br>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). | Drug: Placebo<br>* 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).<br>* Other names: Normal Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scales (VAS) for Pain at 18 Hours Postoperatively | 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. | 18 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sacrocolpopexy, rectocele repair