Standardization of Post-operative Opiate Prescriptions for Same-day Ankle and Wrist Fracture Surgeries

Study Overview
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Brief Summary
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The purpose of this prospective cohort study is to evaluate the opiate prescribing patterns post open reduction and internal fixation (ORIF) of wrist and ankle fractures at the Ottawa Hospital. The primary objective would be to examine the quantity and duration of opiates consumed by the study population, as well as the participant's overall satisfaction with pain control. the investigators will assess whether there is a discrepancy between the quantity of pills prescribed and what is being consumed. With the data collected, the secondary objective would be to create a standardized pain prescription, which the investigators would implement in the second phase of this prospective study. Opiate pills consumed, pain satisfaction and left-over narcotics would again be assessed. The overall goal of this study is to produce an appropriate standardized post-operative prescription, where the number of opiates prescribed mirrors what is being consumed. This would cut down on the quantity of left-over narcotics, helping to reduce the incidence of opiate dependency and diversion in the Ottawa community.

Detailed Description
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This is a multiphase study that will begin with a retrospective review of the prescribing patterns at the Ottawa Hospital. The post-operative prescriptions of 50 wrist fracture and 50 ankle fracture patients booked for same day fracture fixation will be reviewed. The type and quantity of opiate pills prescribed, as well as the other multimodal analgesics prescribed will be collected. Phase one will provide the investigators with data regarding the recent prescribing trends at the Ottawa Hospital prior to beginning the prospective phase of the study. Phase two and three of the study involves collecting data from two prospectively collected cohorts - the standard of care cohort (phase 2) and the standardized prescription cohort (phase 3). In phase two, eligible wrist and ankle fracture patients booked for open reduction and internal fixation through the Walking Wounded (emergency day surgery) program will be recruited and consented via telephone prior to their surgery date. The study participants will receive a post-operative prescription at the discretion of their attending surgeon, fellow or resident, with no intervention from the researchers involved in this study. On post-operative day three and post-operative day ten, these patients will be contacted by phone by the research team and asked to respond verbally to a questionnaire that will record the following measures - quantity of opiates consumed/left-over, pain intensity, satisfaction with pain treatment and other non-opiate medications taken. Using the data collected from phase two, a standardized pain prescription will be created. The average quantity of opiates consumed by the phase two participants will be used to guide the quantity of opiates to be prescribed on the standardized prescription. Similar to recruitment in phase two, in phase three, all eligible patients will be contacted and recruited by telephone prior to their surgery. These patients will be flagged on the day of surgery and given the standardized prescription post-operatively. They will then be asked to respond to the same questionnaires via telephone on post-op day three and post-op day ten.

Official Title
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Standardization of Post-operative Opiate Prescriptions for Same-day Ankle and Wrist Fracture Surgeries

Conditions
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Opioid Use, Post-operative Pain, Prescription Opioid Abuse, Fracture, Ankle, Fracture Wrist, Surgery

Intervention / Treatment
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* Other: Standardized opiate prescription


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ankle and wrist fracture patients booked for ORIF (via Walking Wounded program) Opioid naïve (Opiates prescribed in emergency not included) Competent to give informed consent and respond to questionnaires independently English or French speaking Exclusion Criteria: Admission to hospital pre- or post-operatively Chronic opioid use for pain unrelated to injury Chronic pain in injured extremity, unrelated to acute injury Previous fracture/surgery to injured limb Revision ORIF Dementia or cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of care cohort<br>Eligible wrist and ankle fracture patients booked for open reduction and internal fixation through our emergency day surgery program will be recruited and consented via telephone prior to their surgery date. The study participants will receive a post-operative prescription at the discretion of their attending surgeon, fellow or resident, with no intervention from the researchers involved in this study. On post-operative day three and post-operative day ten, these patients will be contacted by phone by the research team and asked to respond verbally to a questionnaire. Measures including quantity of opiates consumed, pain intensity and satisfaction with pain treatment will be recorded. | |
| Experimental: Standardized prescription cohort<br>Using the data collected from the standard of care cohort, a standardized pain prescription will be created. The average quantity of opiates consumed by the standard of care participants will be used to guide the quantity of opiates to be prescribed on the standardized prescription. In this arm, all eligible patients will be contacted and recruited by telephone prior to their surgery. These patients will be flagged on the day of surgery and given the standardized prescription post-operatively. They will then be asked to respond to the same questionnaires as the standard of care cohort via telephone on post-op day three and post-op day ten. | Other: Standardized opiate prescription<br>* The standardized prescription will include a single opiate, with a fixed dose and number of tablets. It will also include non-opiate adjuncts commonly prescribed at our institution, namely acetaminophen and an anti-inflammatory medication.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported pain satisfaction | Patient reported pain satisfaction between those receiving standard of care, and those receiving the novel standardized prescription will be compared. Treatment satisfaction will be measured using the 11-point ordinal rating of pain intensity (numeric rating scale) and an 11-point ordinal rating of satisfaction with pain relief. In addition to the numerical rating scale, A verbal rating scale (VRS), will also be used to qualify pain control. The VRS consists of a list of descriptors that represent varying degrees of pain intensity. Each of these descriptors has a number associated with it (e.g., 0 = none, 1 = mild pain, 2 = moderate pain, 3 = severe pain, and 4 = intolerable pain). Comparable to the VRS, the Likert scale will similarly be used to qualify treatment satisfaction (e.g., 0 = Very satisfied, 1 = somewhat satisfied, 2 = neither satisfied nor dissatisfied, 3 = somewhat dissatisfied, and 4 = very dissatisfied). | Measures will be recorded on days 3 postoperatively | 
| Patient reported pain satisfaction | Patient reported pain satisfaction between those receiving standard of care, and those receiving the novel standardized prescription will be compared. Treatment satisfaction will be measured using the 11-point ordinal rating of pain intensity (numeric rating scale) and an 11-point ordinal rating of satisfaction with pain relief. In addition to the numerical rating scale, A verbal rating scale (VRS), will also be used to qualify pain control. The VRS consists of a list of descriptors that represent varying degrees of pain intensity. Each of these descriptors has a number associated with it (e.g., 0 = none, 1 = mild pain, 2 = moderate pain, 3 = severe pain, and 4 = intolerable pain). Comparable to the VRS, the Likert scale will similarly be used to qualify treatment satisfaction (e.g., 0 = Very satisfied, 1 = somewhat satisfied, 2 = neither satisfied nor dissatisfied, 3 = somewhat dissatisfied, and 4 = very dissatisfied). | Measures will be recorded on day 10 postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average quantity of opioids prescribed in the standard of care cohort measured using morphine equivalents. | The quantity of opioids prescribed per patient will be converted to Morphine Milligram Equivalents (MME). Data on quantity and types of opiates prescribed, as well as other non-opiate adjuncts, will be collected through EPIC, our institution's electronic health records system. | Prescription information will be collected at a single point prior to post-operative day 3. | 
| Average quantity of opioids consumed post-operatively in both cohorts | The quantity of opiates consumed per patient will be collected on post-operative day three, by asking the study participant to count the number of pills remaining in their opiate prescription bottle. | Measures will be recorded on day 3 postoperatively | 
| Average quantity of opioids consumed post-operatively in both cohorts | The quantity of opiates consumed per patient will be collected on post-operative day ten, by asking the study participant to count the number of pills remaining in their opiate prescription bottle. | Measures will be recorded on day 10 postoperatively | 
| Average quantity of left-over/unused opiates | The quantity of opiates remaining per patient will be collected on post-operative day ten, by asking the study participant to count the number of pills remaining in their opiate prescription bottle. | Post-operative day 10 | 
| Distribution of use of different opioids and non-opioid adjuncts prescribed | The variety of different opiate molecules and non-opiate adjuncts prescribed will be collected and the frequency that each type is being used at our institution will be analyzed. | Prescription information will be collected at a single point prior to post-operative day 3. | 
| The difference in consumption patterns between patients receiving peripheral nerve blocks versus those who haven't received a regional anesthetic. | Average quantity of opioids consumed post-operatively will be compared between the patients receiving peripheral nerve blocks versus those who haven't received a regional anesthetic. | Measures will be recorded on days 3 postoperatively | 
| The difference in consumption patterns between patients receiving peripheral nerve blocks versus those who haven't received a regional anesthetic. | Average quantity of opioids consumed post-operatively will be compared between the patients receiving peripheral nerve blocks versus those who haven't received a regional anesthetic. | Measures will be recorded on day 10 postoperatively |