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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Postoperative Pain, Opioid Use

Intervention / Treatment
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* Other: Liberal post-discharge opioid prescribing
* Other: Restricted post-discharge opioid prescribing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A: liberal post-discharge opioid prescribing<br>Standardized postoperative instructions on non-opioid pain control + liberal opioid prescription provided prior to surgery (standard prescription for opioid prescribed prior to surgery) | Other: Restricted post-discharge opioid prescribing<br>* Opioid only if needed after discharge<br>|
| Experimental: B: restricted post-discharge opioid prescribing<br>Standardized postoperative instructions on non-opioid pain control + opioid prescribed only 'as needed' after discharge | Other: Liberal post-discharge opioid prescribing<br>* Opioid prescribed all patients opioids 'in case they are needed' prior to surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score on postoperative day 1 | Numeric score of pain at end of day (0-10 with 10 being the worst imaginable pain) | postoperative day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with pain control | scale of 1-5 | postoperative day 7 daily scores will be assessed | 
| The number of opioid pills used by those to whom they were prescribed | Count of opioid pills used after surgery | postoperative day 7 daily scores will be assessed | 
| Calls for new opioid prescriptions or refills postoperatively | Phone calls or office visits to obtain pain medication prescription | postoperative day 7 daily outcome will be assessed | 
| Psychometric survey and clinical/demographic factors associated with opioid use postoperatively | Validated survey scores | Upon enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid, midurethral sling