Opioid Use Post-Discharge After Ambulatory Distal Arm Surgery

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: Recruiting
• Conditions: Opioid Use
• Intervention / Treatment: Drug: Standardized Prescription

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: Interventional
• Enrollment (Anticipated): 292
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Impact of Standardized prescription on quality of analgesia after hand and forearm surgery	Twelve weeks after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)		One week, Six weeks and Twelve weeks after intervention
The mean number of days patients require post-discharge opioid medications		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)		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		One week, Six weeks and Twelve weeks after intervention
The incidence of neuropathic pain as diagnosed by DN4 score >3/10		Twelve weeks after intervention compared to pre-intervention
Impact of Standardized prescription on quality of analgesia after hand and forearm surgery		One week after intervention
Impact of Standardized prescription on number of unused opioid medications after hand and forearm surgery		One week after intervention
Impact of Standardized prescription on quality of analgesia after hand and forearm surgery		Six weeks after intervention
Impact of Standardized prescription on number of unused opioid medications after hand and forearm surgery		Six weeks after intervention

Other Outcome Measures

Outcome Measure	Time Frame
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
Correlation of patient depression on opioid consumption	Twelve weeks after intervention compared to pre-intervention
Correlation of patient catastrophizing on pain numerical rating scores (0-10)	Twelve weeks after intervention compared to pre-intervention
Correlation of patient catastrophizing on opioid consumption	Twelve weeks after intervention compared to pre-intervention
Correlation of patient's score on the opioid risk tool (ORT) on post-op opioid use	Twelve weeks after intervention compared to pre-intervention

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2019
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: May 23, 2019
• First Submitted That Met QC Criteria: August 1, 2019
• First Posted (Actual): August 5, 2019

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID 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