Pain and Medication Use Following Surgery

Study Overview
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Brief Summary
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Patients will be randomized to one of two interventions intended to facilitate safe disposal of opioids after cessation following surgery. For pragmatic reasons, participants will be randomized by day to either the information sheet or the disposal bag using a block randomization schedule. To ensuring adequate sample size, patients will be enrolled for a  4-week period following the 2-week usual care run in period. In the event that the sample size estimate has not been reached after the 4-week intervention period, additional patients will be enrolled accordingly.

Detailed Description
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The lack of evidence-based guidelines for postoperative opioid prescribing has contributed to a surplus of opioid pills within our patients' homes and communities, increasing the potential for diversion and nonmedical use. A recent study suggests that for outpatient general surgery procedures, roughly 72% of prescribed opioids go unused. Current opioid disposal options are limited to DEA-authorized opioid collectors, including select law enforcement agencies, pharmacies, or organized pill drop events, and many patients remain unaware of these avenues. Several studies have found that few patients have knowledge about opioid disposal options and even fewer dispose of their unconsumed opioids. Unconsumed opioids pose a diversion risk. In the 2011 National Survey on Drug Use and Health, 70.8% of those who used a prescription medication non-medically obtained the medication from a friend or relative, with or without their knowledge. Additionally, nonmedical prescription opioid use is a common pathway to heroin use. Importantly, over 80% of young intravenous drug users report initiation of prescription opioid misuse prior to heroin. Considering that 40% of the prescriptions written by surgeons are for opioids and patients frequently have excess opioids and limited options for and/or knowledge of opioid disposal, the present study will provide patients with information and novel options for opioid disposal as part of the surgical care pathway.

Official Title
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Safe Opioid Disposal After Surgery Trial

Conditions
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Opioid Use

Intervention / Treatment
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* Behavioral: Information Sheet
* Behavioral: Deterra Drug Deactivation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for surgery at Michigan Medicine's East Ann Arbor Ambulatory Surgery & Medical Procedures Center Exclusion Criteria: Unable to speak English Inability to understand or complete the surveys Other conditions that preclude meaningful participation in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A run-in period will precede the randomization sequence. Individuals will be randomized to one of two groups based on the day of their surgery.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>For the first two weeks, there will be no intervention or changes to the usual discharge instructions | |
| Active Comparator: Information Sheet<br>At discharge, patients will receive an informational sheet detailing options for safe drug disposal | Behavioral: Information Sheet<br>* Patients will receive an informational sheet about how to dispose of leftover opioid medication during discharge. Nurses will provide this information sheet and a brief, scripted description of its use and importance of safe disposal at the time of discharge following surgery.<br>|
| Active Comparator: Deterra Drug Deactivation System<br>At discharge, patients will receive a Deterra Drug Deactivation System. | Behavioral: Information Sheet<br>* Patients will receive an informational sheet about how to dispose of leftover opioid medication during discharge. Nurses will provide this information sheet and a brief, scripted description of its use and importance of safe disposal at the time of discharge following surgery.<br>Behavioral: Deterra Drug Deactivation System<br>* This system is a pouch that deactivates prescription drugs, rendering them ineffective for misuse and safe for regular garbage disposal. It uses a patented activated carbon technology to deactivate drugs, including pills, liquids, and patches, and has been found to be 99% percent effective in studies funded by the National Institute of Drug Abuse (NIDA). Additionally, the pouches are made from environmentally friendly materials and contain active ingredients that are considered non-toxic and pose minimal risk, according to their MSDS. Nurses will provide the Deterra bag and a brief, scripted description of its use and importance of safe disposal at the time of discharge following surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug disposal | Patient-reported disposal of left-over opioid medications in any manner | 4 weeks post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid disposal technique | Patient-reported technique for disposal of left-over opioid medications specifically assessing for safe disposal using recommended disposal methods | 4 weeks post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug disposal