Does Altering Narcotic Prescription Methods Affect Opioid Distribution Following Select Upper Extremity Surgeries?
Completed · Not applicable
Conditions studied: Opioid Use
In brief
It has been well established that prescription opioid misuse and prescription opioid abuse is on the rise. In the late 1990's and early 2000's, there was a large push to make "pain" the fifth vital sign. At the same time, direct-to-consumer advertising and changes in national guidelines laid the groundwork for a decade that would ultimately see the amount of narcotic prescriptions in the United States more than double, and the number of prescription-opioid related deaths more than quadruple. Recently, providers have started to question their own role in this epidemic. In the field of orthopedics in particular, considerable emphasis is now being placed on developing a better understanding of patients postoperative pain requirements, and amending practices to continue to meet those requirements while at the same time responsibly limiting the amount of narcotics that are prescribed. The goal of this project is to further this line of research by testing an opioid prescription model that is designed to easily reconcile clinical practices for prescribing pain medications with individual patient needs. The investigators propose to evaluate a new method for prescribing opioid pain medications that consists of giving patients smaller amounts of narcotics with easier access to refills. It is hypothesized that in this system, patients will ultimately obtain fewer pills from the pharmacy, and will have fewer pills left over following their post-operative recovery. To test this hypothesis, a randomized controlled trial has been designed wherein patients will be given either one single prescription for opioid medications (control group, representing current practice) or multiple small prescriptions for opioid medications that they may fill on an as-needed basis (intervention group). The total amount of narcotics prescribed to both groups will be the same; only the number of prescriptions and the size of each prescription will be altered. Unused narcotic medications are ripe for diversion and may potentially be playing a significant role in the opioid abuse crisis that we are experiencing in the United States. Developing strategies to minimize left over pills while maintaining adequate pain control is perhaps one of the most crucial first steps in addressing this important issue. The success of this model could have broad implications across the healthcare profession. From surgery to emergency medicine and even primary care, this model would be easy to implement and may provide an effective way for the medical community to start to combat the opioid epidemic.
Key facts
- Study ID
- NCT03570320
- Run by
- John Yanik
- People needed
- 48
- Starts
- 2018-09-04
- Expected to finish
- 2020-02-29
- Last updated by the study team
- 2020-03-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Patients at the University of Iowa Hospitals and Clinics will be eligible for this study if they are over the age of 18 and are undergoing outpatient ORIF of isolated unilateral distal radius fractures or first CMC joint arthroplasty.
You may not qualify if…
- Patients will be excluded if they are undergoing surgery for an infection, receiving revision surgery, have multiple injuries that require narcotic use, have a history of chronic narcotic use, or cannot provide informed consent.
Where it is running
- University of Iowa — Iowa City, Iowa, United States
Full record on ClinicalTrials.gov
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