Opioid Use Post-Discharge After Ambulatory Distal Arm Surgery
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Details and patient eligibility
About
The aim of this study is to determine if a standardized evidence-based opioid prescription following elective hand and forearm surgery at Toronto Western Hospital (TWH) will decrease the number of unused opioid pills consumed by patients while still maintaining adequate pain control as compared to usual treatment. Currently, no standardized prescription exists at our institution.
Full description
This study is a Prospective Randomized Controlled Trial with an aim to determine if a standardized discharge prescription provides effective analgesia while reducing the number of unused opioid pills in the community.
All patients presenting to TWH during the recruitment phase for elective ambulatory hand and arm surgery will be asked to participate in the study. Patients will be given information about the study in the pre-operative surgical clinic by the surgeon assessing them. If agreeable, patients will then be approached for recruitment by a research assistant.
Patients would be randomized to either standardized prescription arm versus control arm (usual prescriptions administered by physician).
The standardized prescription will consist of an opioid prescription for Oxycodone 5mg PO q4-6h PRN. Alternatively, if the patient has an allergy or other contraindication to Oxycodone, Hydromorphone 1mg PO q4-6h PRN or Tylenol #3 1-2 tablets PO q4h PRN will be given. The number of tablets prescribed will depend on the extent of surgical trauma, as per a previously conducted study. As part of the standardized prescription group, patients will receive a handout (encouraging them to use non-opioid analgesics along with the opioid prescription to minimize their narcotic consumption).
Participants will be asked a series of questions via telephone consultation or in the pre-operative waiting area about their current opioid use, as well as their risk for narcotic abuse using the opioid risk tool (ORT). Participants will also be asked to fill out questionnaires assessing components of neuropathic pain (DN-4), any elements of anxiety or depression (HADS), and any tendencies for catastrophizing (PCS).
At the time of discharge participants will then be provided with either the standardized prescription or the usual discharge prescription by the surgeon.
Patients will be called after discharge from hospital on post-discharge weeks 1, 6, and 12 by either clinical investigators or research assistants. Patients will be asked standardized questions about their pain with the goal of assessing our primary endpoint of number of opioid pills used as compared to number prescribed. Patients will be attempted to be reached by telephone up to 3 times during the 7 day period following each pre-defined time point (i.e. 1, 6 and 12 weeks).
Subsequently the proportion of unused opioid pills will be calculated for each group.
Enrollment
Sex
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Volunteers
Inclusion criteria
1. Patients presenting to TWH for elective ambulatory hand and forearm surgery
Exclusion criteria
- Chronic opioid treatment, defined as more than 6 tablets of Oxycodone 5 mg per day (or equivalent)
- Cognitive impairment or any other condition causing inability to use 'as required' medication for pain control
- Language barrier preventing completion of patient diary
- Patient refusal
Trial design
Primary purpose
Allocation
Interventional model
Masking
292 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Anuj Bhatia, MD FRCPC
Data sourced from clinicaltrials.gov
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