Recruiting

Observational Study

Sponsor:

Brigham and Women's Hospital

Code:

NCT04564729

Conditions

Knee Arthroplasty, Total

Analgesia

Opioid Use, Unspecified

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Shared Decision Making

Study Details

Brief summary:

This will be a randomized controlled clinical trial in patients who have undergone primary unilateral total knee arthroplasty at Brigham and Women's Faulkner Hospital, Brigham and Women's Hospital and University of Chicago Medical Center. Study subjects will receive either a shared decision aid (SDA) about pain management or standard of care at the time of discharge. The impact of the SDA on the number of leftover opioid pills on postoperative day 30 and average NRS pain score on postoperative day 7 will be assessed.

Conditions

Knee Arthroplasty, Total

Analgesia

Opioid Use, Unspecified

Study ID

NCT04564729

Start date

Nov 2, 2020

Status verified date

May, 2022

Completion date

Sep 30, 2022

Anticipated

Primary completion date

Aug 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Primary unilateral TKA under spinal anesthesia at Brigham \& Women's Faulkner Hospital (BWFH), Brigham and Women's Hospital or University of Chicago Medical Center by a participating surgeon
  • >18 years of age
  • Planned discharge with the typical analgesic medications prescribed at discharge:

  • standing around-the clock Tylenol with or without an NSAID
  • tramadol PRN
  • hydromorphone (dilaudid) or oxycodone PRN

Exclusion Criteria:

  • Diagnosis of dementia
  • <18 years old
  • Contraindication or allergy to opioids
  • Contraindication or allergy to Tylenol
  • Contraindication or allergy to gabapentin
  • History of substance use disorder
  • Preoperative pain requiring a >1-month prescription for >/=45 daily MMEs
  • 4 or more preoperative analgesic prescriptions
  • Hospital admission >1 day
  • Discharge to a skilled nursing facility/inpatient rehabilitation center
  • Non-English speaking patients
  • Requirement for general anesthesia intra-operatively

Study Design

Enrollment

142 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Decision Aid

The shared decision aid (SDA) includes factual information about the World Health Organization pain ladder, the 0-10 numeric rating score pain scale, pharmacologic pain management options, opioid medication benefits and risks and predicted post-discharge opioid requirements based on previous modeling in total knee arthroplasty patients. Subjects in the decision aid group will view the decision aid and have the opportunity to participate in shared decision-making for their discharge opioid prescriptions.

no intervention: Control

Subjects in the control group will undergo standard care and discharge practices. Baseline pain and psychosocial factors will be documented as well as postoperative pain and analgesic consumption.

Interventions

Shared Decision Making

The intervention group will receive a shared decision-making intervention including a decision aid and conversation with a study investigator. The intervention group will have the opportunity to choose the number of opioid pills they receive at discharge from hospital after total knee arthroplasty.

Primary outcome measure

  • Leftover opioid pills [ Time Frame: 30 days postoperatively ]
  • Average 0-10 NRS pain score [ Time Frame: postoperative day 7 ]

Central Contacts and Locations

Central contacts

Naida Cole, MD

9176576692nmcole@bsd.uchicago.edu

Laura Mendez, MD

8574004065lmendez-pino@bwh.harvard.edu

Locations

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Naida Cole, MD

nmcole@bsd.uchicago.edu

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Jose Zeballos, MD

jzeballos@bwh.harvard.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

May 27, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2022-05-27.