Opioid Prescribing Methods for Post-Operative Pain After Urogynecologic Surgery

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Walter Reed National Military Medical Center

Must not be taking: Acetaminophen, NSAIDs

Disqualifiers: Opioid abuse, Pregnancy, Non-English, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different methods of prescribing opioids affect pain control after urogynecologic surgery. Participants will be divided into two groups: one receiving a standard amount of oxycodone and the other a more restricted amount. The researchers aim to assess how these approaches impact pain levels and patient satisfaction. Women scheduled for urogynecologic surgery who can follow study instructions might be eligible to participate. As a Phase 4 trial, this research seeks to understand how an FDA-approved and effective treatment benefits more patients, offering participants a chance to contribute to broader patient care improvements.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these opioid prescribing methods?

Research has shown that giving fewer opioid pills after surgery is generally safe for patients. Studies indicate that using fewer opioids can effectively relieve pain while lowering the risk of long-term addiction. For instance, one study found that using less than a three-day supply of opioids after surgery effectively manages pain.

Both limited and regular opioid prescriptions often involve oxycodone, a common pain medication. Oxycodone is well-researched and usually well-tolerated, but it can cause side effects like nausea or dizziness, which are common with opioids.

In summary, using fewer opioids after surgery appears to be a safe option. Studies support that it helps manage pain and reduces the risk of opioid dependence. ^{1 2 3 4 5}

Why are researchers enthusiastic about this trial?

Researchers are excited about this trial because it explores new methods for opioid prescribing after urogynecologic surgery, aiming to reduce opioid use without compromising pain management. Unlike the standard approach, which typically provides multiple oxycodone tablets, the restricted method gives just one tablet of oxycodone 5mg. This significant reduction could minimize the risk of opioid dependence and side effects, addressing a critical public health issue. The trial could potentially set a new standard for post-operative pain management by demonstrating effective pain relief with fewer opioids.

What evidence suggests that this trial's treatments could be effective for post-operative pain after urogynecologic surgery?

This trial will compare two opioid prescribing methods for post-operative pain following urogynecologic surgery. Research has shown that prescribing fewer opioids after surgery can be effective. Participants in the restricted opioid prescribing arm will receive a limited supply of opioids, consistent with findings that women receiving fewer opioids experienced similar pain relief compared to those receiving the usual amount. One study demonstrated that a limited supply of opioids for three days or less was effective for most patients and reduced the risk of overuse. Patients in the limited group also required less medication overall, with an 83% reduction in the amount prescribed. Clinical guidelines support the use of fewer opioids after surgery as a better approach. Overall, using fewer opioids appears to control pain effectively while reducing risks. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adult women undergoing urogynecologic surgery who can follow the study's instructions and complete all required follow-ups. Participants must be eligible for military healthcare benefits (DEERS) and willing to take either the standard or restricted opioid dose prescribed post-surgery. Women with a history of opioid abuse, those pregnant, breastfeeding, planning pregnancy, or unable to use contraception are excluded.

Inclusion Criteria

I am a woman aged 18 or older.

DEERS eligible

I am scheduled for a pelvic floor surgery.

Exclusion Criteria

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

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.

I am not pregnant, breastfeeding, or planning to become pregnant, and if capable of becoming pregnant, I agree to use reliable contraception during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-operative

Participants attend a routine pre-operative appointment for review of histories, medications, and surgical consents

1 day

1 visit (in-person)

Treatment

Participants undergo urogynecologic surgery and are randomized to either standard or restricted opioid prescribing for post-operative pain control

1 day

1 visit (in-person)

Follow-up

Participants are monitored for satisfaction with post-operative pain control, pain levels, and opioid use

8 weeks

2 visits (in-person) at 7-10 days and 6-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Restricted Opioid Prescribing
• Standard Opioid Prescribing

Trial Overview The study compares patient satisfaction between two groups: one receiving standard opioid prescriptions and another with restricted opioids after urogynecologic surgery. Patients' pain levels and opioid usage will be monitored postoperatively, along with their satisfaction regarding pain control.

How Is the Trial Designed?

Group I: Restricted Opioid Prescribing - Oxycodone HCl 5mg Experimental Treatment 1 Intervention

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

Group II: Standard Opioid Prescribing - Oxycodone HCl 5mg Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Walter Reed National Military Medical Center

Lead Sponsor

Trials

149

Recruited

33,800+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2772973725006009

Restrictive vs. Routine Opioid Prescribing After Prolapse ... Restrictive opioid prescribing is a safe and effective alternative to routine use following prolapse and incontinence surgeries. It maintains patient ...

2. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2800244

Postoperative Restrictive Opioid Protocols and Changes in ... The findings suggest that prescription of an opioid supply of 3 or fewer days is feasible for most postsurgical patients and may be associated with decreased ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8631580/

Longitudinal patient reported outcomes and restrictive ... Women in the restrictive opioid prescribing group had a median reduction in morphine equivalent dose prescribed at discharge of 83%.

4. cdc.gov cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm

CDC Clinical Practice Guideline for Prescribing Opioids ... The systematic review addressed the effectiveness of long-term opioid therapy for outcomes related to pain, function, and quality of life ...

5. contemporaryobgyn.net contemporaryobgyn.net/view/optimizing-pain-management-post-urogynecologic-surgery-with-restrictive-opioid-protocol

Optimizing pain management post urogynecologic surgery ... A recent study suggests that restrictive opioid prescribing protocols post-urogynecologic surgery are as effective as standard protocols ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7440649/

Postsurgical Opioid Prescriptions and Risk of Long-term Use The aim of this study was to evaluate differences in risk of long-term opioid therapy after surgery among an opioid-naive population.

7. mdpi.com mdpi.com/2813-5806/2/4/21

Postoperative Pain and Opioid Use in Urogynecology ... Physician opioid prescribing contributes to this crisis. In urogynecology, most of these prescriptions are aimed at addressing postoperative pain. This expert ...

8. auanet.org auanet.org/guidelines/guidelines/rationale-and-strategies-for-reducing-urologic-post-operative-opioid-prescribing

Rationale and Strategies for Reducing Urologic Post- ... A study utilizing a national insurance claims dataset found an approximately 6% rate of persistent use in opioid-naive patients who were prescribed opioids ...

9. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/17/NCT04491617/Prot_SAP_000.pdf

Restrictive Opioid Prescribing after Surgery for Prolapse ... Outcome Measures. Primary Outcome: Patient satisfaction with pain control at 6 week postoperative visit. Secondary Outcomes: ▫ Pain level ...