NCT05593341

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. 1.Does perioperative education pathway reduce opioid refill requests?
  2. 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. 3.Is there a difference between education provided in-person vs video?
  4. 4.Does perioperative education improve compliance with multimodal analgesia?
  5. 5.Does perioperative education improve appropriate opioid storage?
  6. 6.Does perioperative education improve appropriate opioid disposal?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 25, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2023

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

12 months

First QC Date

September 30, 2022

Last Update Submit

December 23, 2024

Conditions

Keywords

Opioid Education

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 INTERVENTION

Patients are referred to the Hospital's standard 1-hour virtual patient education webinar prior to surgery.

In-person and PDF

EXPERIMENTAL

Patients 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.

Other: Opioid education in person

Video and PDF

EXPERIMENTAL

Patients 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.

Other: Opioid education via video

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

In-person and PDF

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

Video and PDF

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Sheetz 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.

MeSH Terms

Conditions

Pain, PostoperativeOpioid-Related Disorders

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Bradley H Lee, MD

    Hospital for Special Surgery, New York

    PRINCIPAL INVESTIGATOR

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.

Locations