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

92 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Restricted Opioid Prescribing for post-operative pain after urogynecologic surgery?

Research shows that restrictive opioid prescribing can effectively manage pain after surgery without increasing pain levels, as seen in a study where patients reported similar pain control and satisfaction whether they received standard or restricted opioid prescriptions. ^{1 2 3 4 5}

Is restricted opioid prescribing safe for post-operative pain after urogynecologic surgery?

Research on restricted opioid prescribing after urogynecologic surgery suggests it is generally safe, as it aims to reduce the risk of opioid misuse while still managing pain effectively. Studies have shown that patients can achieve satisfactory pain control with fewer opioids, which helps minimize the potential for addiction and other opioid-related risks. ^{1 2 3 4 5}

How does restricted opioid prescribing differ from standard opioid prescribing for post-operative pain after urogynecologic surgery?

Restricted opioid prescribing involves giving opioids only upon patient request after surgery, rather than providing a standard prescription beforehand. This approach aims to reduce the risk of opioid misuse and ensure that patients only use opioids if truly needed, which is different from the traditional method of prescribing a set amount of opioids in advance. ^{1 2 3 4 5}

What is the purpose of this 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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Restrictive opioid prescribing after surgery for prolapse and incontinence: a randomized, noninferiority trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Opioid prescribing practices and medication use following urogynecological surgery. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Multimodal opioid-sparing postoperative pain regimen compared with the standard postoperative pain regimen in vaginal pelvic reconstructive surgery: a multicenter randomized controlled trial. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Opioid Prescriptions After Urogynecologic Surgery Within a Large Health Care Organization: How Much Are We Prescribing? [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Liberal vs. restricted opioid prescribing following midurethral sling dataset. [2023]