Extended Release Local Anesthetic for Postsurgical Pain After Posterior Colporrhaphy and Perineorrhaphy

NCT03875664 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: Pro00024327
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The specific aim of this randomized double-blind clinical trial is to evaluate the effect of intraoperative infiltration of liposomal bupivacaine at the time of posterior colporrhaphy and/or perineorrhaphy on postsurgical pain scores during the first 72 hours after surgery as measured by visual analog scales (VAS) for patients undergoing surgery for pelvic organ prolapse. Study subjects are randomized to 30 mL of liposomal bupivacaine versus 30 mL of injectable normal saline administered in a standardized technique into the posterior vaginal compartment at the time of posterior repair and/or perineorrhaphy.

Conditions

Postoperative Pain

Keywords

liposomal bupivacaine; posterior repair

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain

  As measured by a 100 mm Visual Analog Scale (VAS). This scale ranges from 0-100 mm with 0 mm indicating no pain and 100 mm indicating the most pain. The study is powered to detect a decrease in postoperative pain by 20 mm on this scale, which is considered to be a clinically meaningful difference in prior studies. Results will be reported as mean pain scores at each time point (night of surgery, morning and evening for the first 72 hours after surgery, i.e. until postoperative day#3).

  Night of surgery (POD#0), POD#1 morning, POD#1 evening, POD#2 morning, POD#2 evening, POD#3 morning, POD#3 evening

Secondary Outcomes (9)

• Number of Participants Reporting Satisfaction With Pain Control

  2 weeks after surgery

• Time to First Opioid Administration

  Assessed up to 72 hours after surgery

• Total Opioid Administration

  Cumulatively, over a time period of 72 hours after surgery

• Number of Antiemetic Doses Required Per Participant While Inpatient

  Cumulatively, over a time period of 72 hours after surgery

• Hospital Length of Stay

  Assessed until 30 days after surgery

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Receives 20 mL liposomal bupivacaine expanded with 10 mL of injectable sterile normal saline solution (0.9%) for a total of 30 mL injected in the posterior vaginal compartment in a standardized technique

Drug: Liposomal bupivacaine

Placebo

PLACEBO COMPARATOR

Receives 30 mL of injectable sterile normal 0.9% saline solution injected in the posterior vaginal compartment in a standardized technique

Drug: Placebo - injection

Interventions

Liposomal bupivacaine DRUG

Extended-release local anesthetic

Also known as: EXPAREL 266 mg

Intervention

Placebo - injection DRUG

Injectable normal saline solution

Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study involves women undergoing surgery for pelvic organ prolapse
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking women ages 18 and older undergoing posterior repair and/or perineorrhaphy at our institution for pelvic organ prolapse

You may not qualify if:

• Planned regional anesthesia
• Allergy or contraindication to bupivacaine
• Allergy or contraindication to opioids
• Allergy or contraindication to non-steroidal medications
• Planned laparotomy
• Chronic pain diagnosis and/or chronic narcotic use

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Women's Center for Pelvic Health

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Dr. Sarah Evans
• Organization: Atrium Health

sarah.evans@atriumhealth.org

704-304-1660

Study Officials

• Sarah Evans, MD

  Women's Center for Pelvic Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 15, 2019
• Study Start: July 23, 2018
• Primary Completion: March 12, 2019
• Study Completion: March 31, 2019
• Last Updated: September 13, 2022
• Results First Posted: May 13, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)