Clinical trial NCT05593341: Opioid Education in Total Knee Arthroplasty
Official title: Effect of Perioperative Opioid Education on Outcomes After Total Knee Arthroplasty: A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthropathy of Knee
Post Operative Pain
Opioid Use
Opioid Abuse
Opioid Misuse
Keywords: Opioid Education
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2022-10-25
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Opioid refill at POD 30
timeFrame: Post operative day (POD) 30
measure: Opioid refill at POD 60
timeFrame: Post operative day (POD) 60
Secondary outcomes:
measure: Hospital length of stay
timeFrame: 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)
measure: Patient's health and recovery status following their surgery
timeFrame: 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
measure: Numerical Rating Scale
timeFrame: Post-operative day 0, Post-operative day 1, Post-operative day 7, Post-operative day 14
measure: Opioid consumption
timeFrame: Post-operative day 0, Post-operative day 1, Post-operative day 7, Post-operative day 14
measure: Rates of compliance with multimodal regimen
timeFrame: Post-operative day 1, Post-operative day 7, Post-operative day 14
measure: Rates of proper opioid storage
timeFrame: Post-operative day 7
measure: Rates of proper opioid disposal
timeFrame: Post-operative day 21
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Bradley H Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee BH, Wu CL. Educating Patients Regarding Pain Management and Safe Opioid Use After Surgery: A Narrative Review. Anesth Analg. 2020 Mar;130(3):574-581. doi: 10.1213/ANE.0000000000004436.
citation: Syed UAM, Aleem AW, Wowkanech C, Weekes D, Freedman M, Tjoumakaris F, Abboud JA, Austin LS. Neer Award 2018: the effect of preoperative education on opioid consumption in patients undergoing arthroscopic rotator cuff repair: a prospective, randomized clinical trial. J Shoulder Elbow Surg. 2018 Jun;27(6):962-967. doi: 10.1016/j.jse.2018.02.039. Epub 2018 Mar 26.
citation: Egan KG, De Souza M, Muenks E, Nazir N, Korentager R. Opioid Consumption Following Breast Surgery Decreases with a Brief Educational Intervention: A Randomized, Controlled Trial. Ann Surg Oncol. 2020 Sep;27(9):3156-3162. doi: 10.1245/s10434-020-08432-7. Epub 2020 Apr 13.
citation: Horn A, Kaneshiro K, Tsui BCH. Preemptive and Preventive Pain Psychoeducation and Its Potential Application as a Multimodal Perioperative Pain Control Option: A Systematic Review. Anesth Analg. 2020 Mar;130(3):559-573. doi: 10.1213/ANE.0000000000004319.
citation: Memtsoudis SG, Poeran J, Zubizarreta N, Cozowicz C, Morwald EE, Mariano ER, Mazumdar M. Association of Multimodal Pain Management Strategies with Perioperative Outcomes and Resource Utilization: A Population-based Study. Anesthesiology. 2018 May;128(5):891-902. doi: 10.1097/ALN.0000000000002132.
citation: Stepan JG, Sacks HA, Verret CI, Wessel LE, Kumar K, Fufa DT. Standardized Perioperative Patient Education Decreases Opioid Use after Hand Surgery: A Randomized Controlled Trial. Plast Reconstr Surg. 2021 Feb 1;147(2):409-418. doi: 10.1097/PRS.0000000000007574.
citation: Nahhas CR, Hannon CP, Yang J, Gerlinger TL, Nam D, Della Valle CJ. Education Increases Disposal of Unused Opioids After Total Joint Arthroplasty: A Cluster-Randomized Controlled Trial. J Bone Joint Surg Am. 2020 Jun 3;102(11):953-960. doi: 10.2106/JBJS.19.01166.
citation: Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.