Opioid Education in Total Knee Arthroplasty
Effect of Perioperative Opioid Education on Outcomes After Total Knee Arthroplasty: A Randomized Study
1 other identifier
interventional
42
1 country
1
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 27, 2022
CompletedFirst Submitted
Initial submission to the registry
September 30, 2022
CompletedFirst Posted
Study publicly available on registry
October 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 11, 2023
CompletedDecember 27, 2024
December 1, 2024
12 months
September 30, 2022
December 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Opioid refill at POD 30
Patients will be asked if they have refilled their opioid prescription and the number of opioid refills.
Post operative day (POD) 30
Opioid refill at POD 60
Patients will be asked if they have refilled their opioid prescription and the number of opioid refills.
Post operative day (POD) 60
Secondary Outcomes (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)
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
Numerical Rating Scale
Post-operative day 0, 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 compliance with multimodal regimen
Post-operative day 1, Post-operative day 7, Post-operative day 14
- +2 more secondary outcomes
Study Arms (3)
Control Group
NO INTERVENTIONPatients are referred to the Hospital's standard 1-hour virtual patient education webinar prior to surgery.
In-person and PDF
EXPERIMENTALPatients will receive two in-person education sessions (1st session before surgery and 2nd session after surgery). Patients will also receive pdf handouts about opioids and pain management.
Video and PDF
EXPERIMENTALPatients will receive two video education sessions (1st session before surgery and 2nd session after surgery). Patients will also receive pdf handouts about opioids and pain management.
Interventions
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
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
Eligibility Criteria
You may qualify if:
- Age between age 18 and 80 years old
- Undergoing primary total knee replacement surgery at Hospital for Special Surgery
- English speaking
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital for Special Surgery
New York, New York, 10021, United States
Related Publications (9)
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.
PMID: 31567320RESULTSyed 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.
PMID: 29599038RESULTEgan 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.
PMID: 32285282RESULTHorn 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.
PMID: 31335400RESULTMemtsoudis 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.
PMID: 29498951RESULTStepan 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.
PMID: 33235041RESULTNahhas 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.
PMID: 32251139RESULTOsterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.
PMID: 16079372RESULTSheetz M, Puglisi A, Trentalange M, Reichel J, Chalmers B, Gonzalez Della Valle A, Sideris A, Lee BH. Comparing modalities of opioid education in patients undergoing total knee arthroplasty: a randomized pilot trial. Reg Anesth Pain Med. 2026 Jan 5;51(1):60-68. doi: 10.1136/rapm-2024-105701.
PMID: 39327049DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bradley H Lee, MD
Hospital for Special Surgery, New York
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2022
First Posted
October 25, 2022
Study Start
September 27, 2022
Primary Completion
September 11, 2023
Study Completion
September 11, 2023
Last Updated
December 27, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share
There is no plan to make IPD available to other researchers.