Clinical trial NCT04044820: Opioid Use Post-Discharge After Ambulatory Distal Arm Surgery
Official title: Discharge Opioid Prescription for Ambulatory Hand and Forearm Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2019-08-05
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Impact of Standardized prescription on quality of analgesia after hand and forearm surgery
timeFrame: Twelve weeks after intervention
Secondary outcomes:
measure: Incidence of adverse effects of opioid medications experienced by patients
timeFrame: One week, Six weeks and Twelve weeks after intervention
measure: Correlation of opioid consumption to pain scores
timeFrame: One week, Six weeks and Twelve weeks after intervention
measure: Correlation of opioid consumption to functional limitations post-operatively as measured by the Disabilities of Arm Shoulder and Hand (DASH) score
timeFrame: Six weeks and Twelve weeks after intervention compared to pre-intervention
measure: Incidence of disposal practices of prescribed opioids by patients
timeFrame: One week, Six weeks and Twelve weeks after intervention
measure: Patient satisfaction with pain management after discharge (as measured on a 0 to 10 scale, 0 being completely dissatisfied, and 10 being completely satisfied)
timeFrame: One week, Six weeks and Twelve weeks after intervention
measure: The mean number of days patients require post-discharge opioid medications
timeFrame: One week, Six weeks and Twelve weeks after intervention
measure: The correlation between in-hospital opioid analgesic requirements and post-discharge opioid consumption (all converted to oral morphine equivalents)
timeFrame: One week, Six weeks and Twelve weeks after intervention
measure: 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
timeFrame: One week, Six weeks and Twelve weeks after intervention
measure: The incidence of neuropathic pain as diagnosed by DN4 score >3/10
timeFrame: Twelve weeks after intervention compared to pre-intervention
measure: Impact of Standardized prescription on quality of analgesia after hand and forearm surgery
timeFrame: One week after intervention
measure: Impact of Standardized prescription on number of unused opioid medications after hand and forearm surgery
timeFrame: One week after intervention
measure: Impact of Standardized prescription on quality of analgesia after hand and forearm surgery
timeFrame: Six weeks after intervention
measure: Impact of Standardized prescription on number of unused opioid medications after hand and forearm surgery
timeFrame: Six weeks after intervention
Other outcomes:
measure: Correlation of patient anxiety on pain numerical rating scores (0-10)
timeFrame: Twelve weeks after intervention compared to pre-intervention
measure: Correlation of patient anxiety on opioid consumption
timeFrame: Twelve weeks after intervention compared to pre-intervention
measure: Correlation of patient depression on pain numerical rating scores (0-10)
timeFrame: Twelve weeks after intervention compared to pre-intervention
measure: Correlation of patient depression on opioid consumption
timeFrame: Twelve weeks after intervention compared to pre-intervention
measure: Correlation of patient catastrophizing on pain numerical rating scores (0-10)
timeFrame: Twelve weeks after intervention compared to pre-intervention
measure: Correlation of patient catastrophizing on opioid consumption
timeFrame: Twelve weeks after intervention compared to pre-intervention
measure: Correlation of patient's score on the opioid risk tool (ORT) on post-op opioid use
timeFrame: Twelve weeks after intervention compared to pre-intervention
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: UHN
name: Anuj Bhatia, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: