Patient Satisfaction With Opioid Restriction After Urogynecologic Surgery

NCT06731348 | Enrolling By Invitation Phase 4 DMC FDA Drug

• 1 other identifier: WRNMMC-2024-0454
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Satisfaction; Opioid Use After Surgery; Urogynecologic Surgery

Keywords

Patient Satisfaction; Opioid Use after Urogynecologic Surgery

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction with post-operative pain control

  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.

  post-operative day 7-10

Secondary Outcomes (6)

• 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

Study Arms (2)

Standard Opioid Prescribing - Oxycodone HCl 5mg

ACTIVE COMPARATOR

Participants will receive standard opioid prescribing - Oxycodone 5mg x10 tablets for major cases, 5 tablets for minor cases.

Drug: standard opioid prescribing

Restricted Opioid Prescribing - Oxycodone HCl 5mg

EXPERIMENTAL

Participants in the restricted opioid prescribing group will receive restricted opioid prescribing after surgery. They will receive 1 tablet of Oxycodone HCl 5mg

Drug: restricted opioid prescribing

Interventions

restricted opioid prescribing DRUG

Participants in the restricted opioid prescribing group will receive restricted opioid prescribing after surgery. They will receive 1 tablet of Oxycodone HCl 5mg.

Restricted Opioid Prescribing - Oxycodone HCl 5mg

standard opioid prescribing DRUG

Participants will receive standard opioid prescribing - Oxycodone HCl 5mg x10 tablets for major cases, 5 tablets for minor cases.

Standard Opioid Prescribing - Oxycodone HCl 5mg

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: December 12, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 11, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)