Opioid UseNCT04044820
Opioid Use Post-Discharge After Ambulatory Distal Arm Surgery
A study testing Standardized Prescription in people with Opioid Use, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use
- What is being tested?
- Standardized Prescription
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 siteCanada
- Study dates
- 4 Mar 2019to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients presenting to TWH for elective ambulatory hand and forearm surgery
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T2S8
Anuj Bhatia, MD FRCPC, (416) 603 5800 ext. 2308, anuj.bhatia@uhn.ca
Danielle Alvares, (416) 603 5800 ext. 3517, danielle.alvares@uhn.ca
About this study
Official title: Discharge Opioid Prescription for Ambulatory Hand and Forearm Surgery: A Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Opioid Use
- Being tested
- Standardized Prescription
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized PrescriptionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Standardized Discharge Prescription | Active comparator | Based on a previous study examining mean number of opioid pills used by patients undergoing elective, unilateral hand and forearm surgery Receives: Drug: Standardized Prescription |
| Usual Discharge Prescription | No intervention | Routine standard of care involves prescription for opioids at the discretion of the surgical team |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Standardized prescription on quality of analgesia after hand and forearm surgery
Measured: Twelve weeks after intervention
Secondary outcomes (13)
Incidence of adverse effects of opioid medications experienced by patients
Measured: One week, Six weeks and Twelve weeks after intervention
Correlation of opioid consumption to pain scores
Measured: One week, Six weeks and Twelve weeks after intervention
Correlation of opioid consumption to functional limitations post-operatively as measured by the Disabilities of Arm Shoulder and Hand (DASH) score
Measured: Six weeks and Twelve weeks after intervention compared to pre-intervention
Incidence of disposal practices of prescribed opioids by patients
To indicate the type and incidence of disposal practices of prescribed opioids for patients (returned to pharmacy, retaining pills at home, and self-disposal of medication by participants
Measured: One week, Six weeks and Twelve weeks after intervention
Patient satisfaction with pain management after discharge (as measured on a 0 to 10 scale, 0 being completely dissatisfied, and 10 being completely satisfied)
Measured: One week, Six weeks and Twelve weeks after intervention
The mean number of days patients require post-discharge opioid medications
Measured: One week, Six weeks and Twelve weeks after intervention
The correlation between in-hospital opioid analgesic requirements and post-discharge opioid consumption (all converted to oral morphine equivalents)
Measured: One week, Six weeks and Twelve weeks after intervention
The proportion of patients that require additional opioid prescription(s), on top of what is given at discharge, during the follow-up period, and 12 weeks
Measured: One week, Six weeks and Twelve weeks after intervention
The incidence of neuropathic pain as diagnosed by DN4 score >3/10
Measured: Twelve weeks after intervention compared to pre-intervention
Impact of Standardized prescription on quality of analgesia after hand and forearm surgery
Measured: One week after intervention
Impact of Standardized prescription on number of unused opioid medications after hand and forearm surgery
Measured: One week after intervention
Impact of Standardized prescription on quality of analgesia after hand and forearm surgery
Measured: Six weeks after intervention
Impact of Standardized prescription on number of unused opioid medications after hand and forearm surgery
Measured: Six weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start4 Mar 2019
- Primary completionDec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 292 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anuj Bhatia, MD FRCPC, Principal investigator, UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044820
- Sponsor's protocol ID
- 18-5539
- Status last verified
- Jan 2026
- First submitted
- 23 May 2019
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discharge Opioid Prescription for Ambulatory Hand and Forearm Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04044820
- Acronym / sponsor ID
- 18-5539
- Conditions
- Opioid Use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 292 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized Discharge Prescription | Active comparator | Drug: Standardized PrescriptionBased on a previous study examining mean number of opioid pills used by patients undergoing elective, unilateral hand and forearm surgery |
| Usual Discharge Prescription | No intervention | –Routine standard of care involves prescription for opioids at the discretion of the surgical team |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients presenting to TWH for elective ambulatory hand and forearm surgery
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized PrescriptionOxycodone 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. | Drug | Standardized Discharge Prescription |
Primary outcome
Impact of Standardized prescription on quality of analgesia after hand and forearm surgery
Time frame: Twelve weeks after intervention
13 secondary outcomes
Incidence of adverse effects of opioid medications experienced by patients
Time frame: One week, Six weeks and Twelve weeks after intervention
Correlation of opioid consumption to pain scores
Time frame: One week, Six weeks and Twelve weeks after intervention
Correlation of opioid consumption to functional limitations post-operatively as measured by the Disabilities of Arm Shoulder and Hand (DASH) score
Time frame: Six weeks and Twelve weeks after intervention compared to pre-intervention
Incidence of disposal practices of prescribed opioids by patients
Time frame: One week, Six weeks and Twelve weeks after intervention
Patient satisfaction with pain management after discharge (as measured on a 0 to 10 scale, 0 being completely dissatisfied, and 10 being completely satisfied)
Time frame: One week, Six weeks and Twelve weeks after intervention
The mean number of days patients require post-discharge opioid medications
Time frame: One week, Six weeks and Twelve weeks after intervention
The correlation between in-hospital opioid analgesic requirements and post-discharge opioid consumption (all converted to oral morphine equivalents)
Time frame: One week, Six weeks and Twelve weeks after intervention
The proportion of patients that require additional opioid prescription(s), on top of what is given at discharge, during the follow-up period, and 12 weeks
Time frame: One week, Six weeks and Twelve weeks after intervention
The incidence of neuropathic pain as diagnosed by DN4 score >3/10
Time frame: Twelve weeks after intervention compared to pre-intervention
Impact of Standardized prescription on quality of analgesia after hand and forearm surgery
Time frame: One week after intervention
Impact of Standardized prescription on number of unused opioid medications after hand and forearm surgery
Time frame: One week after intervention
Impact of Standardized prescription on quality of analgesia after hand and forearm surgery
Time frame: Six weeks after intervention
Impact of Standardized prescription on number of unused opioid medications after hand and forearm surgery
Time frame: Six weeks after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anuj Bhatia, MD FRCPC principal investigator
UHN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Prescription in people with Opioid Use, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anuj Bhatia, MD FRCPC ((416) 603 5800 ext. 6136, anuj.bhatia@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Standardized prescription on quality of analgesia after hand and forearm surgery (time frame: Twelve weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.