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Completed

NCT Number: NCT02449915

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

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.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Cincinnati Urogynecology Associates

Cincinnati, Ohio, 45220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

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).

Other names: Exparel

Placebo

Drug

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).

Other names: Normal Saline

Primary outcomes

  1. Visual Analog Scales (VAS) for Pain at 18 Hours Postoperatively

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 20, 2015
Registry last updated
Dec 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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