Opioid Use Post-Discharge After Ambulatory Distal Arm Surgery
NCT ID: NCT04044820
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
292 participants
INTERVENTIONAL
2019-03-04
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standardized Discharge Prescription
Based on a previous study examining mean number of opioid pills used by patients undergoing elective, unilateral hand and forearm surgery
Standardized Prescription
Oxycodone 5mg PO q4-6h PRN
If patient has allergy or other contraindications
Hydromorphone 1mg PO q4-6h PRN/ Tylenol #3 1-2 tablets PO q4h PRN
The number of tablets prescribed will depend on the extent of surgical trauma
* 0-5 pills for simple surgeries such as a trigger finger release
* 10 pills for carpal tunnel or Dupuytren's contracture releases
* 15 pills for a ganglion cyst excision or simple tendon transfer
* 20 pills for more complex procedures such as distal forearm ORIF or a wrist fusion.
Usual Discharge Prescription
Routine standard of care involves prescription for opioids at the discretion of the surgical team
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Standardized Prescription
Oxycodone 5mg PO q4-6h PRN
If patient has allergy or other contraindications
Hydromorphone 1mg PO q4-6h PRN/ Tylenol #3 1-2 tablets PO q4h PRN
The number of tablets prescribed will depend on the extent of surgical trauma
* 0-5 pills for simple surgeries such as a trigger finger release
* 10 pills for carpal tunnel or Dupuytren's contracture releases
* 15 pills for a ganglion cyst excision or simple tendon transfer
* 20 pills for more complex procedures such as distal forearm ORIF or a wrist fusion.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
2. Cognitive impairment or any other condition causing inability to use 'as required' medication for pain control
3. Language barrier preventing completion of patient diary
4. Patient refusal
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Health Network, Toronto
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anuj Bhatia, MD FRCPC
Role: PRINCIPAL_INVESTIGATOR
UHN
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Toronto Western Hospital
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Anuj Bhatia, MD FRCPC
Role: primary
Danielle Alvares
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
18-5539
Identifier Type: -
Identifier Source: org_study_id