NCT06731348

Patient Satisfaction With Opioid Restriction After Urogynecologic Surgery

Patient Satisfaction With Opioid Restriction After Urogynecologic Surgery: A Randomized Non-Inferiority Trial

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Walter Reed National Military Medical Center · Federal
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients undergoing surgery with the Walter Reed National Military Medical Center Urogynecology Clinic will be randomized to either standard opioid prescribing or restricted opioid prescribing. They will be surveyed on their satisfaction with their postoperative pain control and their pain levels and opioid use will be tracked postoperatively.

Detailed description

This study is a 2 arm, unmasked, single center, randomized controlled, non-inferiority study comparing participant satisfaction with post-operative pain control between participants randomized to a restrictive opioid prescribing protocol versus a standard opioid prescribing protocol. All females aged 18 years and older who are scheduled for a minor or major urogynecologic surgery who are receiving care at Walter Reed National Military Medical Center (WRNMMC) Urogynecology clinic will be eligible for the study. Of note, all those seen in the WRNMMC Urogynecologic clinic are female. Minor surgeries will include colporrhaphy, midurethral sling placement, vaginal mesh removal or revision, urethral diverticulectomy, or vaginal cyst excision. Major surgeries will include vaginal vault suspension, minimally invasive (laparoscopic or robotic) sacrocolpopexy, minimally invasive (laparoscopic or robotic) hysteropexy, and colpocleisis. Major cases may or may not include hysterectomy and/or bilateral salpingectomy at the time of surgery. Prior to the scheduled surgical procedure, the participant will present for an in-person, routine pre-operative appointment which is standard of care in our practice and involves a review of the participant's histories and medications, as well as signing surgical consents and reviewing pre- and post-operative instructions. All participants will receive standardized pre-operative and post-operative counseling as is standard of care in our clinical practice. Participants will be randomized to determine the protocol assignment - standard opioid prescribing or restricted opioid prescribing. Standard opioid prescribing participants will be prescribed the standard opioid prescription - 5 tablets of Oxycodone HCl 5mg for minor procedures, 10 tablets of Oxycodone HCl 5mg for major procedures - for post-operative pain control. Restricted opioid prescribing participants will be prescribed 1 tablet of Oxycodone HCl 5mg for both minor and major procedures. Participants will follow-up at 7-10 days and 6-8 weeks to determine their satisfaction with their post-operative pain control, as well as their pain levels and opioid use post-operatively.

Conditions

• Patient Satisfaction
• Opioid Use After Surgery
• Urogynecologic Surgery

Interventions

Type	Name	Description
DRUG	restricted opioid prescribing	Participants in the restricted opioid prescribing group will receive restricted opioid prescribing after surgery. They will receive 1 tablet of Oxycodone HCl 5mg.
DRUG	standard opioid prescribing	Participants will receive standard opioid prescribing - Oxycodone HCl 5mg x10 tablets for major cases, 5 tablets for minor cases.

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2024-12-12
• Last updated: 2025-06-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study