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Completed

NCT Number: NCT04277975

Liberal vs. Restricted Post-discharge Opioid Prescribing Following Midurethral Sling

The specific objective of this proposal is to evaluate pain and opioid use following a midurethral sling (MUS) under two different opioid prescribing schemes. The central hypothesis is that, in spite of the fact that opioids are often routinely prescribed by many surgeons following this procedure, most patients do not require them for pain control, and patients who are not prescribed postoperative will have similar pain scores and pain control satisfaction compared with patients who are routinely prescribed a standard amount of opioids for postoperative pain control.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

About this study

The investigators have 3 specific aims:

Specific Aim #1: Compare patients' postoperative pain experience and satisfaction with pain control using two different opioid prescribing schemes.

The investigators' working hypothesis is that postoperative pain control and satisfaction will be non-inferior between patients routinely prescribed opioids vs. those not routinely prescribed opioids prior to surgery.

Participants will be asked to complete a pain diary and assessment of their pain control satisfaction postoperatively. Pain control will be assessed by Likert scores (0-10) and satisfaction with pain control will be queried using an integer scale of 0-5 using REDCap or paper survey for the first 7 days postoperatively.

Specific Aim #2: Examine the opioid use of patients following midurethral sling.

The investigators will test the hypothesis that most patients who undergo MUS do not use prescribed opioid regardless of prescription scheme.

Given the investigators' standard of care preoperative education, including detailed instruction on non-opioid related pain management, they will prospectively examine the use of opioids after MUS under two different opioid prescribing routines. Women who agree to participation will be randomized to either be discharged home from surgery with a standard opioid prescription vs. only prescribed opioids if requested. The amount of opioid used will be collected via REDCap or paper survey for the first 7 days postoperatively. Investigators will also assess the subsequent requests for opioid prescription (among those not routinely given opioid prescription at discharge) or refill (among those who are initially given a standard amount of opioid upon discharge).

Specific Aim #3: Predict postoperative pain and opioid use after MUS with a brief psychometric questionnaire.

The investigators will leverage brief psychometric survey instruments in combination with individual demographic and clinical factors to predict postoperative pain and opioid use following MUS. They will seek to identify patients at risk for higher opioid needs or other pain interventions preoperatively, with a view to target education, prevention, and interventions on this population.

The project is original in comparing current clinical prescribing patterns with restrictive opioid prescribing. It capitalizes on providers' new ability to electronically prescribe opioids for patients who require them after discharge from the hospital, thereby decreasing the potential impact on patients and providers if prescribed opioid is requested once the patient has been discharged. The proposed work is innovative, because it examines recently developed psychometric survey instruments to identify patients at risk of postoperative pain. At the completion of this project, it is the investigators' expectation that the combination of work proposed in aims 1 -3 will optimize prescribing of opioids following this common MUS procedure, reducing the potential for both excessive opioid use (and adverse sequelae) postoperatively as well as unused opioid for subsequent misuse.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scheduled to undergo isolated midurethral sling after evaluation and discussion with surgeon
  • Consent to participate in this study

Exclusion criteria

  • Pregnant or breast feeding
  • Cognitively impaired women
  • Pre-existing diagnosis of opioid use disorder
  • Patients with chronic daily opioid use
  • Prisoners
  • Non-English speaking or inability to read, as a result of the need to read and report daily results in English
  • Allergy to oral opioids used in this study (oxycodone)
  • Significant contraindications (allergy, severe hepatic or renal compromise, or other medical conditions deemed by surgeon) to the use of both NSAIDs (ibuprofen, naproxen) and acetaminophen

Treatment and study plan

Liberal post-discharge opioid prescribing

Other

Opioid prescribed all patients opioids 'in case they are needed' prior to surgery

Restricted post-discharge opioid prescribing

Other

Opioid only if needed after discharge

Primary outcomes

  1. Pain score on postoperative day 1

    Time frame: postoperative day 1

    Numeric score of pain at end of day (0-10 with 10 being the worst imaginable pain)

Secondary outcomes

  1. Satisfaction with pain control

    Time frame: postoperative day 7 daily scores will be assessed

    scale of 1-5

  2. The number of opioid pills used by those to whom they were prescribed

    Time frame: postoperative day 7 daily scores will be assessed

    Count of opioid pills used after surgery

  3. Calls for new opioid prescriptions or refills postoperatively

    Time frame: postoperative day 7 daily outcome will be assessed

    Phone calls or office visits to obtain pain medication prescription

  4. Psychometric survey and clinical/demographic factors associated with opioid use postoperatively

    Time frame: Upon enrollment

    Validated survey scores

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

A Randomized Trial of Liberal vs. Restricted Post-discharge Opioid Prescribing Following Midurethral Sling

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 20, 2020
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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