Patient SatisfactionPhase 4NCT06731348
Patient Satisfaction With Opioid Restriction After Urogynecologic Surgery
A Phase 4 study testing restricted opioid prescribing and standard opioid prescribing in people with Patient Satisfaction and Opioid Use After Surgery, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Patient Satisfaction, Opioid Use After Surgery, Urogynecologic Surgery
- What is being tested?
- restricted opioid prescribing and standard opioid prescribing
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 1 Jul 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
Official title: Patient Satisfaction With Opioid Restriction After Urogynecologic Surgery: A Randomized Non-Inferiority Trial
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.
Read the 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.
- Being tested
- restricted opioid prescribing, standard opioid prescribing
- Keywords
- Patient Satisfaction, Opioid Use after Urogynecologic Surgery
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
restricted opioid prescribingDrug
Participants in the restricted opioid prescribing group will receive restricted opioid prescribing after surgery. They will receive 1 tablet of Oxycodone HCl 5mg.
standard opioid prescribingDrug
Participants will receive standard opioid prescribing - Oxycodone HCl 5mg x10 tablets for major cases, 5 tablets for minor cases.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: restricted opioid prescribing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: post-operative day 7-10
Secondary outcomes (6)
Participant satisfaction with post-operative pain control at 6-8 weeks post-operatively
Measured: post-operative weeks 6-8
Difference in satisfaction with post-operative pain control between POD 7-10 and 6-8 weeks post-operatively.
Measured: post-operative week 6-8
Post-operative opioid use on POD 1-7
Measured: post-operative days 1-7
Patient pain scores on POD 1-7
Measured: post-operative days 1-7
Postoperative opioid refill rates over 6 weeks post-operatively
Measured: post-operative week 6
Participant utilization of health care resources over 6 weeks post-operatively.
Measured: post-operative week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start1 Dec 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731348
- Sponsor's protocol ID
- WRNMMC-2024-0454
- Status last verified
- Dec 2024
- First submitted
- 4 Nov 2024
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction With Opioid Restriction After Urogynecologic Surgery: A Randomized Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT06731348
- Acronym / sponsor ID
- WRNMMC-2024-0454
- Keywords
- Patient Satisfaction, Opioid Use after Urogynecologic Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Opioid Prescribing - Oxycodone HCl 5mg | Active comparator | Drug: standard opioid prescribingParticipants will receive standard opioid prescribing - Oxycodone 5mg x10 tablets for major cases, 5 tablets for minor cases. |
| Restricted Opioid Prescribing - Oxycodone HCl 5mg | Experimental | Drug: restricted opioid prescribingParticipants in the restricted opioid prescribing group will receive restricted opioid prescribing after surgery. They will receive 1 tablet of Oxycodone HCl 5mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| restricted opioid prescribingParticipants 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 - Oxycodone HCl 5mg |
| standard opioid prescribingParticipants will receive standard opioid prescribing - Oxycodone HCl 5mg x10 tablets for major cases, 5 tablets for minor cases. | Drug | Standard Opioid Prescribing - Oxycodone HCl 5mg |
Primary outcome
Patient satisfaction with post-operative pain control
Time frame: 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.
6 secondary outcomes
Participant satisfaction with post-operative pain control at 6-8 weeks post-operatively
Time frame: post-operative weeks 6-8
Difference in satisfaction with post-operative pain control between POD 7-10 and 6-8 weeks post-operatively.
Time frame: post-operative week 6-8
Post-operative opioid use on POD 1-7
Time frame: post-operative days 1-7
Patient pain scores on POD 1-7
Time frame: post-operative days 1-7
Postoperative opioid refill rates over 6 weeks post-operatively
Time frame: post-operative week 6
Participant utilization of health care resources over 6 weeks post-operatively.
Time frame: post-operative week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing restricted opioid prescribing and standard opioid prescribing in people with Patient Satisfaction and Opioid Use After Surgery, run by Walter Reed National Military Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction with post-operative pain control (time frame: post-operative day 7-10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.