Patient Satisfaction with Opioid Restriction After Urogynecologic Surgery

Phase 4

• Conditions: Patient Satisfaction; Opioid Use After Surgery; Urogynecologic Surgery
• Interventions: Drug: standard opioid prescribing; Drug: restricted opioid prescribing

• Registration Number: NCT06731348
• Lead Sponsor: Walter Reed National Military Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2024-11-04
• Status Verified: 2024-12
• Study Start: 2024-12-01
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study First Posted: 2024-12-12
• Last Update Posted: 2024-12-12
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 92

Inclusion Criteria

• Females 18 years of age and older
• Scheduled for urogynecologic surgical procedure
• Ability to follow study instructions and complete all required follow-up
• DEERS eligible
• Willing to take the SOC opioid dose or the restricted dose

Exclusion Criteria

• Ineligible for non-opioid pain medication, including allergy to acetaminophen or NSAIDS
• History of opioid abuse determined by asking the potential participant about history of opioid abuse and reviewing potential participant's chart to look for prior or active diagnosis of opioid abuse.
• Females who are breastfeeding, pregnant or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study
• Inability to speak or read English. Non-English speakers will be excluded from this study for ease of being able to allow the principal investigator to communicate with the patients during the consents, initial and all follow-up communication. Some of the questionnaires used have also only been validated in English.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Opioid Prescribing - Oxycodone HCl 5mg	standard opioid prescribing	Participants will receive standard opioid prescribing - Oxycodone 5mg x10 tablets for major cases, 5 tablets for minor cases.
Restricted Opioid Prescribing - Oxycodone HCl 5mg	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

Primary Outcome Measures

Name	Time	Method
Patient satisfaction with post-operative pain control	post-operative day 7-10	Satisfaction with post-operative pain control on post-operative day (POD) 7-10 in participants undergoing urogynecologic surgery who receive either the routine opioid prescribing protocol or the restrictive prescribing protocol.

Secondary Outcome Measures

Name	Time	Method
Participant satisfaction with post-operative pain control at 6-8 weeks post-operatively	post-operative weeks 6-8
Difference in satisfaction with post-operative pain control between POD 7-10 and 6-8 weeks post-operatively.	post-operative week 6-8
Post-operative opioid use on POD 1-7	post-operative days 1-7
Patient pain scores on POD 1-7	post-operative days 1-7
Postoperative opioid refill rates over 6 weeks post-operatively	post-operative week 6
Participant utilization of health care resources over 6 weeks post-operatively.	post-operative week 6

Trial Locations

Locations (1)

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States