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

NCT02449915 | Completed Phase 4 Results

• 1 other identifier: 14-079
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse

Keywords

sacrocolpopexy; rectocele repair

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Bupivacaine Arm

EXPERIMENTAL

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

Placebo Arm

PLACEBO COMPARATOR

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

Interventions

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).

Also known as: Exparel

Bupivacaine Arm

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).

Also known as: Normal Saline

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

Cincinnati Urogynecology Associates

Cincinnati, Ohio, 45220, United States

Location

Related Publications (1)

• 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.

  PMID: 29215511 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Jennifer Yeung, DO
• Organization: TriHealth Inc.

Jennifer_Yeung@trihealth.com

513-463-4300

Study Officials

• Rachel Pauls, MD

  Cincinnati Urogynocolgy Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2015
• First Posted: May 20, 2015
• Study Start: March 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: December 8, 2017
• Results First Posted: December 8, 2017

Record last verified: 2017-11

Locations

US (1)