Expectations and Pain Control Advancement In surgeRy: The REPAIR Trial

Study Overview
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Brief Summary
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This is a randomized control trial that aims to evaluate whether patient-centered education, compared to routine education, decreases narcotic consumption without interfering with return to physical activity following hospital discharge. In addition, it will test whether patient-centered education decreases the quantity of narcotics prescribed and/or increases patient satisfaction and preparedness.

Detailed Description
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Opioid use disorder is a national health emergency. Opioid prescribing practices to treat post-operative pain have contributed to the problem. This study seeks to explore the effects of changing pre-operative education & increasing patient input regarding post-operative receipt of opioids. The study will explore the effects that change in pre-operative education may have on post-operative opioid consumption juxtaposed upon return to physical activity using a randomized trial design. Women undergoing pelvic floor reconstructive surgery will be randomized to either (i) standard pre-operative education (ii) modified, patient-centered pre-operative education. The investigators will monitor both post-operative opioid consumption and return to physical activity. The investigators hypothesize that investigation of patient's post-operative pain experiences and their inclusion in the educational and the shared decision-making process will likely decrease post-operative narcotic use without affecting return to function. Our long-term goal is to develop a pragmatic and balanced approach to address pain concerns, decreasing the medical community's contribution to the opioid epidemic.

Official Title
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Randomized Trial on Expectations and Pain Control Advancement In surgeRy: The REPAIR Trial

Conditions
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Abuses Over-The-Counter/Prescription Medications, Pain, Postoperative, Opioid Use, Physical Activity, Patient Dependence on

Intervention / Treatment
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* Behavioral: Patient centered pre-op education
* Behavioral: routine preop education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects are ≥ 18 years of age English or Spanish speaking Patient scheduled for pelvic floor surgery Exclusion Criteria: Unable to speak English or Spanish Using long acting opioids (e.g. MS Contin, Fentanyl patch) Primary or Pain Healthcare Provider recommends against study participation (eg. If the patient has a history of opioid use disorder or other confounding problems, we will contact the Primary Care Provider or Pain Healthcare Provider for their recommendations regarding study participation)

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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No

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient Centered pre-op education<br>Patient centered pre-operative education and patient centered post-operative care. | Behavioral: Patient centered pre-op education<br>* To implement a patient centered education intervention to evaluate post-op narcotic use.<br>|
| Active Comparator: Routine Pre-op education<br>Participants will receive routine pre-operative education and post-op will receive a standardized number of narcotics | Behavioral: routine preop education<br>* To implement routine patient education intervention to evaluate post-op narcotic use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid use at approximately two weeks post-op | Morphine milligram equivalents at the two weeks post-op | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid use at approximately six to eight weeks post-op | Morphine milligram equivalents at the six to eight weeks post-op | 6-8 weeks |