Opioid Requirements Post Discharge of Patients Having Total Knee Arthroplasty (TKA)

Sponsor
Sunnybrook Health Sciences Centre (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03106129
Collaborator
(none)
200
1
70.6
2.8

Study Details

Study Description

Brief Summary

Total knee arthroplasty (TKA) may result in significant postoperative pain. The majority of these patients are prescribed opioids for the management of postoperative pain. Recent evidence has highlighted that postoperative opioids are being over-prescribed resulting in opioid misuse and abuse. Over-prescribing also results in a significant financial cost. This prospective observational study was designed to determine the mean amount of opioid required after TKA. This data can be used in the future as a guide to change our current practice of prescribing with the aim to reduce over-prescription.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Over prescription of opioids is currently a National epidemic . There is a call for action to address this problem urgently and anesthesiologists are well positioned to participate and lead through research to educate medical practitioners of how to prescribe the optimal dose with the ultimate goal of improved patient's safety.

    Total knee arthroplasy (TKA) and total hip arthroplasty (THA) may result in significant and sustained postoperative pain. For optimal pain control, faster recovery, and better functional rehabilitation, these patients are prescribed opioids in addition to analgesic adjuncts in hospital and after discharge from the hospital. This practice stems from much evidence that demonstrated a propensity for moderate and severe pain of 52% and 16% respectively up to 30 days post discharge in patients undergoing THA and TKA.

    These patients are prescribed opioids upon discharge from the hospital to control pain and to enhance optimal rehabilitation. The discharge prescription is often based on a surgeon's judgment and past experience. Furthermore, more than 50% of patients may receive suboptimal pain control resulting in pain in the early postoperative period. On the other hand, recent studies have shown that opioids are often over-prescribed. This practice not only results in a significant financial cost, but also represents a potential reservoir for opioid misuse and abuse. In Canada, the rate of dispensing high-dose opioid formulations (greater than 200mg morphine equivalents per day) increased 23.0%, from 781 units per 1000 population in 2006 to 961 units per 1000 population in 2011. Excessive opioid prescriptions can lead to excessive morbidity and mortality as evidenced in the United States where 16 917 (74%) of the 22,810 deaths relating to pharmaceutical overdose involved opioid analgesics. With respect to the financial burden, in the United States in 2007, prescription opioid abuse costs were $55.7 billion of which 45% were healthcare costs (e.g., abuse treatment).

    To the author's knowledge there are no widely used objective tools or guidelines to instruct patients in self-administering opioids post-discharge or to help surgeons to avoid over or under prescribing. This may contribute to either over-dosing with opioid related side effects, or under-dosing with inadequate analgesia and rehabilitation.

    In this prospective observational study we plan to determine the mean amount of opioid required post discharge after TKA that correlates with good pain management and rehabilitation outcomes. The mean amount of opioid consumed could be used in the future to guide physicians to practice proper opioid prescribing post discharge from hospital.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Opioid Requirements Post Discharge of Patients Having Total Knee Arthroplasty (TKA)
    Actual Study Start Date :
    Feb 9, 2017
    Anticipated Primary Completion Date :
    Jul 30, 2022
    Anticipated Study Completion Date :
    Dec 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. The amount of opioid analgesics used and the number remaining [6 weeks after surgery]

      A member of the research team will contact the participant weekly after their surgery. Over the phone the team member will collect the total amount of opioid taken and the total amount of opioid remaining.

    Secondary Outcome Measures

    1. The amount of non-opioid analgesics consumed [6 weeks after surgery]

      The team member will contact the participant weekly to ask about the number of other non-opioid analgesics consumed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 18 years or older

    • Having an elective total knee replacement done at Sunnybrook Holland Orthopaedic and Arthritic Centre.

    • All participants must speak English and have no communication barriers.

    Exclusion Criteria:
    • If you are taking >10mg morphine equivalents per day

    • Deemed incompetent to be able to self prescribe opioids.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4Y 1H1

    Sponsors and Collaborators

    • Sunnybrook Health Sciences Centre

    Investigators

    • Principal Investigator: Imad Awad, MBChB, Sunnybrook Health Sciences Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Sunnybrook Health Sciences Centre
    ClinicalTrials.gov Identifier:
    NCT03106129
    Other Study ID Numbers:
    • 309-2016
    First Posted:
    Apr 10, 2017
    Last Update Posted:
    Apr 4, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 4, 2022