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Completed

NCT Number: NCT05593341

Opioid Education in Total Knee Arthroplasty

The goal of this experimental study is to compare different education intervention on opioid education for patients undergoing total knee arthroplasty. The specific research questions to address are:

1. Does perioperative education pathway reduce opioid refill requests? 2. Is education pathway that focuses on pain management provided in-person and via video in repeated sessions more effective than current standard of care education consisting of a single exposure given as part of a broader preoperative presentation covering multiple topics? 3. Is there a difference between education provided in-person vs video? 4. Does perioperative education improve compliance with multimodal analgesia? 5. Does perioperative education improve appropriate opioid storage? 6. Does perioperative education improve appropriate opioid disposal?

Enrolled patients will be assigned at random to one of 3 study groups. Group 1 (control): Patients are referred to the hospital's standard 1-hour virtual patient education webinar prior to surgery.

Group 2 (in-person): Patients will receive two in-person education sessions (1st session before surgery and 2nd session after surgery). Patients will also receive portable document format (pdf) handouts about opioid and pain management.

Group 3 (video): Patients will receive two video education sessions (1st session before surgery and 2nd session after surgery). Patients will also receive pdf handouts about opioid and pain management.

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Key information

Conditions

Arthropathy of Knee Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Neurologic Manifestations Opioid Abuse Opioid Misuse Opioid Use Opioid-Related Disorders Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Pain Postoperative Complications Signs and Symptoms Substance-Related Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Special Surgery

New York, 10021, United States

About this study

Patients undergoing surgery are frequently unaware of how to properly use opioids for pain management which may result in poor compliance with pain regimens, worse pain control and functional outcomes, and improper storage and disposal. There is evidence that educational interventions in various formats may improve pain and promote proper opioid handling. In addition, multimodal analgesia has been shown to be effective in total joint arthroplasty, and setting appropriate expectations may reduce anxiety, postoperative recovery time, and post surgical acute pain.

The current education process at HSS involves patient referral to a virtual webinar which is optional. Pain topics are covered within a broader 50-minute presentation on numerous topics related to surgery. Information on pain topics may be difficult to process and retain because it is a single exposure that is combined with multiple unrelated topics, and there is no repetition or reference provided. The aim of this study is to explore how a comprehensive educational pathway focusing on aspects of pain control and proper opioid use with repeated sessions will affect outcomes after total knee arthroplasty by comparing three groups - 1) patients who attend the virtual webinar, 2) an in-person session with a portable document format (PDF), and 3) a video session with PDF.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between age 18 and 80 years old
  • Undergoing primary total knee replacement surgery at Hospital for Special Surgery
  • English speaking

Exclusion criteria

  • History of chronic opioid use (continuous opioid use for 3 or more months)
  • Opioid use within the past 3 months
  • Contraindication to NSAIDs or acetaminophen
  • Contraindication or allergy to opioids
  • Contraindication to any study medications (i.e., fentanyl, ketamine, versed, acetaminophen, ketorolac, zofran, decadron)
  • Discharge to rehab or skilled nursing facility (opioids are not prescribed by HSS providers)
  • Contraindication or refusal to receive neuraxial anesthesia or peripheralnerve blocks (PNB)
  • Revision surgery
  • Ambulatory surgery
  • Patients who are pregnant

Treatment and study plan

Opioid education in person

Other

The presentation and handouts contain information regarding the following topics:

  • Reviewing opioids and strategies for analgesia
  • Defining and identifying opioids
  • Goals for postoperative pain management and utilizing opioids to treat pain
  • Alternative modes of treating pain
  • Regional anesthesia/analgesia defined
  • Side effects and risks of opioids
  • Common side effects of opioids
  • Risks of addiction, tolerance, dependence, opioid-induced hyperalgesia with long-term use
  • Proper use and handling of opioids
  • Safe practices when taking opioids
  • Weaning off opioids
  • Safe storage and disposal of opioids

Opioid education via video

Other

The video and handouts contain information regarding the following topics:

  • Reviewing opioids and strategies for analgesia
  • Defining and identifying opioids
  • Goals for postoperative pain management and utilizing opioids to treat pain
  • Alternative modes of treating pain
  • Regional anesthesia/analgesia defined
  • Side effects and risks of opioids
  • Common side effects of opioids
  • Risks of addiction, tolerance, dependence, opioid-induced hyperalgesia with long-term use
  • Proper use and handling of opioids
  • Safe practices when taking opioids
  • Weaning off opioids
  • Safe storage and disposal of opioids

Primary outcomes

  1. Opioid refill at POD 30

    Time frame: Post operative day (POD) 30

    Patients will be asked if they have refilled their opioid prescription and the number of opioid refills.

  2. Opioid refill at POD 60

    Time frame: Post operative day (POD) 60

    Patients will be asked if they have refilled their opioid prescription and the number of opioid refills.

Secondary outcomes

  1. Hospital length of stay

    Time frame: From the time patient enters the post-anesthesia care unit (PACU entry) until the time patient is discharged from the hospital (discharge time), assessed up to 168 hours (1 week)

    The total amount of time spent in-patient following their surgery.

  2. Patient's health and recovery status following their surgery

    Time frame: Pre-operative (when patient is in the holding area being prepped for surgery), Post-operative day 1, Post-operative day 7, Post-operative day 14

    A survey titled: quality of recovery 15 (QoR15) is a patient- reported outcome measure measuring quality of recovery after surgery and anesthesia.

    Each of the following question on the survey will be assessed on a 0-10 scale, with 0 meaning "none of the time" and 10 meaning "all of the time".

    How have you been feeling in the last 24 hours?

    • Able to breathe easily
    • Been able to enjoy food
    • Feeling rested
    • Have had a good sleep
    • Able to look after personal toilet and hygiene unaided
    • Able to communicate with family or friends
    • Getting support from hospital doctors and nurses
    • Able to return to work or usual home activities
    • Feeling comfortable and in control
    • Having a feeling of general well-being

    Have you had any of the following in the last 24 hours?

    • Moderate pain
    • Severe pain
    • Nausea or vomiting
    • Feeling worried or anxious
    • Feeling sad or depressed

  3. Numerical Rating Scale

    Time frame: Post-operative day 0, Post-operative day 1, Post-operative day 7, Post-operative day 14

    Patients are asked to report a number between 0 and 10 that best measures their pain intensity. Zero represents 'no pain at all' whereas 10 represents 'the worst pain ever possible'.

  4. Opioid consumption

    Time frame: Post-operative day 0, Post-operative day 1, Post-operative day 7, Post-operative day 14

    The amount of opioid consumption by the patient (in oral morphine equivalents).

  5. Rates of compliance with multimodal regimen

    Time frame: Post-operative day 1, Post-operative day 7, Post-operative day 14

    Patients will keep "pain diary" to record use of each medication (acetaminophen, NSAIDs, and opioid). Compliance will be defined as the percentage of prescribed medication (acetaminophen or NSAID) that is actually taken.

  6. Rates of proper opioid storage

    Time frame: Post-operative day 7

    Patients will be asked to report how they are storing their opioids (i.e., stored "locked and hidden").

  7. Rates of proper opioid disposal

    Time frame: Post-operative day 21

    Patients will be asked to report how they are disposing of their unused opioids (i.e., reporting they dispose using one of the accepted proper disposal methods).

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

Effect of Perioperative Opioid Education on Outcomes After Total Knee Arthroplasty: A Randomized Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 25, 2022
Registry last updated
Dec 27, 2024

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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