Opioid Use Post-Discharge After Ambulatory Distal Arm Surgery

NCT04044820 | Recruiting

• 1 other identifier: 18-5539
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

Brief 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. Currently, no standardized prescription exists at our institution.

Conditions

Opioid Use

Outcome Measures

Primary Outcomes (1)

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

  Twelve weeks after intervention

Secondary Outcomes (13)

• Incidence of adverse effects of opioid medications experienced by patients

  One week, Six weeks and Twelve weeks after intervention

• Correlation of opioid consumption to pain scores

  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

  Six weeks and Twelve weeks after intervention compared to pre-intervention

• Incidence of disposal practices of prescribed opioids by patients

  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)

  One week, Six weeks and Twelve weeks after intervention

Other Outcomes (7)

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

  Twelve weeks after intervention compared to pre-intervention

• Correlation of patient anxiety on opioid consumption

  Twelve weeks after intervention compared to pre-intervention

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

  Twelve weeks after intervention compared to pre-intervention

Study Arms (2)

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

Drug: Standardized Prescription

Usual Discharge Prescription

NO INTERVENTION

Routine standard of care involves prescription for opioids at the discretion of the surgical team

Interventions

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.

Standardized Discharge Prescription

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T2S8, Canada

RECRUITING

Study Officials

• Anuj Bhatia, MD FRCPC

  UHN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anuj Bhatia, MD FRCPC

CONTACT

(416) 603 5800; anuj.bhatia@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: August 5, 2019
• Study Start: March 4, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)