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NCT Number: NCT04044820

Opioid Use Post-Discharge After Ambulatory Distal Arm Surgery

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Standardized Prescription

Drug

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.

Primary outcomes

  1. Impact of Standardized prescription on quality of analgesia after hand and forearm surgery

    Time frame: Twelve weeks after intervention

Secondary outcomes

  1. Incidence of adverse effects of opioid medications experienced by patients

    Time frame: One week, Six weeks and Twelve weeks after intervention

  2. Correlation of opioid consumption to pain scores

    Time frame: One week, Six weeks and Twelve weeks after intervention

  3. 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

  4. 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

  5. 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

  6. The mean number of days patients require post-discharge opioid medications

    Time frame: One week, Six weeks and Twelve weeks after intervention

  7. 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

  8. 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

  9. The incidence of neuropathic pain as diagnosed by DN4 score >3/10

    Time frame: Twelve weeks after intervention compared to pre-intervention

  10. Impact of Standardized prescription on quality of analgesia after hand and forearm surgery

    Time frame: One week after intervention

  11. Impact of Standardized prescription on number of unused opioid medications after hand and forearm surgery

    Time frame: One week after intervention

  12. Impact of Standardized prescription on quality of analgesia after hand and forearm surgery

    Time frame: Six weeks after intervention

  13. Impact of Standardized prescription on number of unused opioid medications after hand and forearm surgery

    Time frame: Six weeks after intervention

Other outcomes

  1. Correlation of patient anxiety on pain numerical rating scores (0-10)

    Time frame: Twelve weeks after intervention compared to pre-intervention

  2. Correlation of patient anxiety on opioid consumption

    Time frame: Twelve weeks after intervention compared to pre-intervention

  3. Correlation of patient depression on pain numerical rating scores (0-10)

    Time frame: Twelve weeks after intervention compared to pre-intervention

  4. Correlation of patient depression on opioid consumption

    Time frame: Twelve weeks after intervention compared to pre-intervention

  5. Correlation of patient catastrophizing on pain numerical rating scores (0-10)

    Time frame: Twelve weeks after intervention compared to pre-intervention

  6. Correlation of patient catastrophizing on opioid consumption

    Time frame: Twelve weeks after intervention compared to pre-intervention

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Anuj Bhatia, MD FRCPC

CONTACT

[email protected]

(416) 603 5800 ext. 6136

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Discharge Opioid Prescription for Ambulatory Hand and Forearm Surgery: A Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2019
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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