Opioid Use Post-Discharge After Ambulatory Distal Arm Surgery

January 14, 2026 updated by: University Health Network, Toronto

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
292

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T2S8
        • Recruiting
        • Toronto Western Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

1. Patients presenting to TWH for elective ambulatory hand and forearm surgery

Exclusion Criteria:

  1. Chronic opioid treatment, defined as more than 6 tablets of Oxycodone 5 mg per day (or equivalent)
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standardized Discharge Prescription
Based on a previous study examining mean number of opioid pills used by patients undergoing elective, unilateral hand and forearm surgery
Drug: 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.
No Intervention: Usual Discharge Prescription
Routine standard of care involves prescription for opioids at the discretion of the surgical team

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Impact of Standardized prescription on quality of analgesia after hand and forearm surgery
Time Frame: Twelve weeks after intervention
Twelve weeks after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse effects of opioid medications experienced by patients
Time Frame: One week, Six weeks and Twelve weeks after intervention
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
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
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
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
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
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
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
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
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
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
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
One week after intervention
Impact of Standardized prescription on quality of analgesia after hand and forearm surgery
Time Frame: Six weeks after intervention
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
Six weeks after intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Correlation of patient anxiety on pain numerical rating scores (0-10)
Time Frame: Twelve weeks after intervention compared to pre-intervention
Twelve weeks after intervention compared to pre-intervention
Correlation of patient anxiety on opioid consumption
Time Frame: Twelve weeks after intervention compared to pre-intervention
Twelve weeks after intervention compared to pre-intervention
Correlation of patient depression on pain numerical rating scores (0-10)
Time Frame: Twelve weeks after intervention compared to pre-intervention
Twelve weeks after intervention compared to pre-intervention
Correlation of patient depression on opioid consumption
Time Frame: Twelve weeks after intervention compared to pre-intervention
Twelve weeks after intervention compared to pre-intervention
Correlation of patient catastrophizing on pain numerical rating scores (0-10)
Time Frame: Twelve weeks after intervention compared to pre-intervention
Twelve weeks after intervention compared to pre-intervention
Correlation of patient catastrophizing on opioid consumption
Time Frame: Twelve weeks after intervention compared to pre-intervention
Twelve weeks after intervention compared to pre-intervention
Correlation of patient's score on the opioid risk tool (ORT) on post-op opioid use
Time Frame: Twelve weeks after intervention compared to pre-intervention
Twelve weeks after intervention compared to pre-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Health Network, Toronto

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anuj Bhatia, MD FRCPC, UHN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 4, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18-5539

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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