Surgery Clinical Trial
Official title:
Standardization of Post-operative Opiate Prescriptions for Same-day Ankle and Wrist Fracture Surgeries
Verified date | April 2022 |
Source | The Ottawa Hospital |
Contact | Zoe Rubin, M.D. |
Phone | 5147549514 |
zrubin[@]toh.ca | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 2022 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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The Ottawa Hospital |
Adalbert JR, Ilyas AM. Implementing Prescribing Guidelines for Upper Extremity Orthopedic Procedures: A Prospective Analysis of Postoperative Opioid Consumption and Satisfaction. Hand (N Y). 2021 Jul;16(4):491-497. doi: 10.1177/1558944719867122. Epub 2019 Aug 23. — View Citation
Bhashyam AR, Basilico M, Weaver MJ, Harris MB, Heng M. Using Historical Variation in Opioid Prescribing Immediately After Fracture Surgery to Guide Maximum Initial Prescriptions. J Orthop Trauma. 2019 Apr;33(4):e131-e136. doi: 10.1097/BOT.0000000000001392. — View Citation
Helmerhorst GTT, Zwiers R, Ring D, Kloen P. Pain Relief After Operative Treatment of an Extremity Fracture: A Noninferiority Randomized Controlled Trial. J Bone Joint Surg Am. 2017 Nov 15;99(22):1908-1915. doi: 10.2106/JBJS.17.00149. — View Citation
Kim N, Matzon JL, Abboudi J, Jones C, Kirkpatrick W, Leinberry CF, Liss FE, Lutsky KF, Wang ML, Maltenfort M, Ilyas AM. A Prospective Evaluation of Opioid Utilization After Upper-Extremity Surgical Procedures: Identifying Consumption Patterns and Determining Prescribing Guidelines. J Bone Joint Surg Am. 2016 Oct 19;98(20):e89. — View Citation
Sabatino MJ, Kunkel ST, Ramkumar DB, Keeney BJ, Jevsevar DS. Excess Opioid Medication and Variation in Prescribing Patterns Following Common Orthopaedic Procedures. J Bone Joint Surg Am. 2018 Feb 7;100(3):180-188. doi: 10.2106/JBJS.17.00672. — View Citation
Saini S, McDonald EL, Shakked R, Nicholson K, Rogero R, Chapter M, Winters BS, Pedowitz DI, Raikin SM, Daniel JN. Prospective Evaluation of Utilization Patterns and Prescribing Guidelines of Opioid Consumption Following Orthopedic Foot and Ankle Surgery. Foot Ankle Int. 2018 Nov;39(11):1257-1265. doi: 10.1177/1071100718790243. Epub 2018 Aug 19. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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. | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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. | |
Secondary | 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 | |
Secondary | 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 |
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