Pain and Medication Use Following Surgery (SODAS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03179566|
Recruitment Status : Completed
First Posted : June 7, 2017
Last Update Posted : September 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Opioid Use||Behavioral: Information Sheet Behavioral: Deterra Drug Deactivation System||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||391 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||None (Open Label)|
|Official Title:||Safe Opioid Disposal After Surgery Trial|
|Actual Study Start Date :||June 6, 2017|
|Actual Primary Completion Date :||September 1, 2017|
|Actual Study Completion Date :||September 1, 2017|
No Intervention: Usual Care
For the first two weeks, there will be no intervention or changes to the usual discharge instructions
Active Comparator: Information Sheet
At discharge, patients will receive an informational sheet detailing options for safe drug disposal
Behavioral: Information Sheet
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.
Active Comparator: Deterra Drug Deactivation System
At discharge, patients will receive a Deterra Drug Deactivation System.
Behavioral: Information Sheet
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.Behavioral: Deterra Drug Deactivation System
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.
- Drug disposal [ Time Frame: 4 weeks post-surgery ]Patient-reported disposal of left-over opioid medications in any manner
- Opioid disposal technique [ Time Frame: 4 weeks post-surgery ]Patient-reported technique for disposal of left-over opioid medications specifically assessing for safe disposal using recommended disposal methods
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03179566
|United States, Michigan|
|East Ann Arbor Ambulatory Surgery & Medical Procedures Center - Michigan Medicine|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Chad Brummett, MD||Michigan Medicine, Department of Anesthesiology|