Effect of Perioperative Opioid Education on Outcomes After Total Knee Arthroplasty: A Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Opioid refill at POD 30
研究概览
简要总结
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:
- Does perioperative education pathway reduce opioid refill requests?
- 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?
- Is there a difference between education provided in-person vs video?
- Does perioperative education improve compliance with multimodal analgesia?
- Does perioperative education improve appropriate opioid storage?
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between age 18 and 80 years old
- •Undergoing primary total knee replacement surgery at Hospital for Special Surgery
- •English speaking
排除标准
- •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
结局指标
主要结局
Opioid refill at POD 30
时间窗: Post operative day (POD) 30
Patients will be asked if they have refilled their opioid prescription and the number of opioid refills.
Opioid refill at POD 60
时间窗: Post operative day (POD) 60
Patients will be asked if they have refilled their opioid prescription and the number of opioid refills.
次要结局
- Rates of compliance with multimodal regimen(Post-operative day 1, Post-operative day 7, Post-operative day 14)
- Rates of proper opioid storage(Post-operative day 7)
- Hospital length of stay(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))
- Numerical Rating Scale(Post-operative day 0, Post-operative day 1, Post-operative day 7, Post-operative day 14)
- Patient's health and recovery status following their surgery(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)
- Opioid consumption(Post-operative day 0, Post-operative day 1, Post-operative day 7, Post-operative day 14)
- Rates of proper opioid disposal(Post-operative day 21)