Toronto Western Hospital
Toronto, Ontario, M5T2S8, Canada
Location status: Recruiting
Location contact
Anuj Bhatia, MD FRCPC
CONTACT
(416) 603 5800 ext. 2308
Danielle Alvares
CONTACT
(416) 603 5800 ext. 3517
NCT Number: NCT04044820
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Toronto, Ontario, M5T2S8, Canada
Location status: Recruiting
Anuj Bhatia, MD FRCPC
CONTACT
(416) 603 5800 ext. 2308
Danielle Alvares
CONTACT
(416) 603 5800 ext. 3517
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Twelve weeks after intervention
Time frame: One week, Six weeks and Twelve weeks after intervention
Time frame: One week, Six weeks and Twelve weeks after intervention
Time frame: Six weeks and Twelve weeks after intervention compared to pre-intervention
Time frame: One week, Six weeks and Twelve weeks after intervention
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
Time frame: One week, Six weeks and Twelve weeks after intervention
Time frame: One week, Six weeks and Twelve weeks after intervention
Time frame: One week, Six weeks and Twelve weeks after intervention
Time frame: One week, Six weeks and Twelve weeks after intervention
Time frame: Twelve weeks after intervention compared to pre-intervention
Time frame: One week after intervention
Time frame: One week after intervention
Time frame: Six weeks after intervention
Time frame: Six weeks after intervention
Time frame: Twelve weeks after intervention compared to pre-intervention
Time frame: Twelve weeks after intervention compared to pre-intervention
Time frame: Twelve weeks after intervention compared to pre-intervention
Time frame: Twelve weeks after intervention compared to pre-intervention
Time frame: Twelve weeks after intervention compared to pre-intervention
Time frame: Twelve weeks after intervention compared to pre-intervention
Time frame: Twelve weeks after intervention compared to pre-intervention
Contact information is provided by the study sponsor or research team.
University Health Network, Toronto
Other
Discharge Opioid Prescription for Ambulatory Hand and Forearm Surgery: A Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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