Clinical trial NCT03179566: Pain and Medication Use Following Surgery
Official title: Safe Opioid Disposal After Surgery Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Keywords: drug disposal
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Michigan Department of Health and Human Services
First posted: 2017-06-07
Enrollment: 391
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Drug disposal
timeFrame: 4 weeks post-surgery
Secondary outcomes:
measure: Opioid disposal technique
timeFrame: 4 weeks post-surgery
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: East Ann Arbor Ambulatory Surgery & Medical Procedures Center - Michigan Medicine
state: Michigan
Study officials:
affiliation: Michigan Medicine, Department of Anesthesiology
name: Chad Brummett, MD
role: PRINCIPAL_INVESTIGATOR
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