Opioid Use Post-Discharge After Ambulatory Distal Arm Surgery

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04044820
• Other study ID #: 18-5539
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2022
• Source: University Health Network, Toronto
• Contact: Anuj Bhatia, MD FRCPC
• Phone: (416) 603 5800
• Email: anuj.bhatia[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 292
• Est. completion date: December 31, 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use

Intervention

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.

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation of patient anxiety on pain numerical rating scores (0-10)		Twelve weeks after intervention compared to pre-intervention
Other	Correlation of patient anxiety on opioid consumption		Twelve weeks after intervention compared to pre-intervention
Other	Correlation of patient depression on pain numerical rating scores (0-10)		Twelve weeks after intervention compared to pre-intervention
Other	Correlation of patient depression on opioid consumption		Twelve weeks after intervention compared to pre-intervention
Other	Correlation of patient catastrophizing on pain numerical rating scores (0-10)		Twelve weeks after intervention compared to pre-intervention
Other	Correlation of patient catastrophizing on opioid consumption		Twelve weeks after intervention compared to pre-intervention
Other	Correlation of patient's score on the opioid risk tool (ORT) on post-op opioid use		Twelve weeks after intervention compared to pre-intervention
Primary	Impact of Standardized prescription on quality of analgesia after hand and forearm surgery		Twelve weeks after intervention
Secondary	Incidence of adverse effects of opioid medications experienced by patients		One week, Six weeks and Twelve weeks after intervention
Secondary	Correlation of opioid consumption to pain scores		One week, Six weeks and Twelve weeks after intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	The mean number of days patients require post-discharge opioid medications		One week, Six weeks and Twelve weeks after intervention
Secondary	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
Secondary	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
Secondary	The incidence of neuropathic pain as diagnosed by DN4 score >3/10		Twelve weeks after intervention compared to pre-intervention
Secondary	Impact of Standardized prescription on quality of analgesia after hand and forearm surgery		One week after intervention
Secondary	Impact of Standardized prescription on number of unused opioid medications after hand and forearm surgery		One week after intervention
Secondary	Impact of Standardized prescription on quality of analgesia after hand and forearm surgery		Six weeks after intervention
Secondary	Impact of Standardized prescription on number of unused opioid medications after hand and forearm surgery		Six weeks after intervention