Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04044820
Study type Interventional
Source University Health Network, Toronto
Contact Anuj Bhatia, MD FRCPC
Phone (416) 603 5800
Email anuj.bhatia@uhn.ca
Status Recruiting
Phase N/A
Start date March 4, 2019
Completion date December 31, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04095624 - Does Preoperative Pain Medication Management Influence Surgical Outcomes in Spinal Fusion N/A
Completed NCT04484610 - Appropriate Opioid Quantities for Acute Pain - Pharmacist Study Phase 4
Recruiting NCT04598074 - Opioid Package Prototype (OPP) N/A
Recruiting NCT06033599 - Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement Phase 3
Recruiting NCT06032559 - Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment Phase 3
Completed NCT05845177 - Persistent Pain After Hip Replacement
Completed NCT03268551 - MEMO-Medical Marijuana and Opioids Study
Completed NCT03570320 - Does Altering Narcotic Prescription Methods Affect Opioid Distribution Following Select Upper Extremity Surgeries? N/A
Completed NCT04526236 - Influence of Aging on Perioperative Methadone Dosing Phase 4
Completed NCT05593341 - Opioid Education in Total Knee Arthroplasty N/A
Recruiting NCT05877157 - Pain AND Opioids After Surgery
Recruiting NCT06055205 - A Pain and Coordination Plan for Reduced Opioid Use After Accidental Injuries N/A
Recruiting NCT03675386 - Reducing Opioid Use for Chronic Pain Patients Following Surgery N/A
Suspended NCT05001789 - Cognitive Functioning in Opioid Use Disorder N/A
Completed NCT04296396 - Opioid Prescription After Cesarean Trial Phase 3
Not yet recruiting NCT04868552 - Naloxone Education in Total Joint Patients N/A
Completed NCT03540030 - Opioid-Free Shoulder Arthroplasty Phase 4
Terminated NCT06217380 - Feasibility and Acceptability of Oxygen Saturation Monitoring Using Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program N/A
Recruiting NCT05976646 - Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion Phase 1/Phase 2
Completed NCT03472521 - Prevention of Persistent Opioid Use in Mothers Phase 4