Improvement of Pain Following Robotic Sacrocolpopexy and Rectocele Repair for Pelvic Organ Prolapse
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/10/2017 |
| Start Date: | March 2015 |
| End Date: | August 2016 |
Does Liposomal Bupivacaine Improve Pain Following Robotic Sacrocolpopexy and Rectocele Repair for Pelvic Organ Prolapse? A Randomized Placebo Controlled Trial
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.
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.
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.
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.
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
We found this trial at
1
site
Cincinnati, Ohio 45220
Principal Investigator: Rachel N Pauls, MD
Phone: 513-853-4213
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