Duloxetine RCT on Postop TKA Outcomes

Description

The aim of this study is to determine if duloxetine is associated with differences in post-operative pain, patient-reported outcome measures, and opioid consumption in patients undergoing primary total knee arthroplasty compared to patients who do not receive the medication. If so, duloxetine has the potential to become widely incorporated into the multi-modal analgesic regimen given to patients following knee replacements.

Conditions

Pain, Postoperative, Total Knee Arthroplasty

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Study Overview

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Study Details

Study overview

The aim of this study is to determine if duloxetine is associated with differences in post-operative pain, patient-reported outcome measures, and opioid consumption in patients undergoing primary total knee arthroplasty compared to patients who do not receive the medication. If so, duloxetine has the potential to become widely incorporated into the multi-modal analgesic regimen given to patients following knee replacements.

A Prospective, Triple-Blind, Randomized Controlled Trial Evaluating Duloxetine on Post-Operative Outcomes Following Primary Total Knee Arthroplasty in Patients with and Without Central Sensitization

Duloxetine RCT on Postop TKA Outcomes

Condition
Pain, Postoperative
Intervention / Treatment

-

Contacts and Locations

Chicago

Rush University medical Center, Chicago, Illinois, United States, 60612

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Any patient undergoing primary total knee arthroplasty for osteoarthritis
  • * Age ≥ 18 years old
  • * Willingness to undergo randomization and return for all scheduled visits
  • * English speaking
  • * Age \> 80 years old
  • * American Society of Anesthesiologists (ASA) Score ≥ 4
  • * Prior use of SSRIs or SNRIs
  • * Use of serotonergic drugs in the past 6 months with the exception of tramadol
  • * Known psychiatric disorder (specifically: generalized anxiety disorder, major depressive disorder, type I or type II bipolar disorder, and schizophrenia)
  • * Heavy alcohol consumption defined as ≥ 14 drinks per week for men and ≥ 7 drinks per week for women
  • * Opioid tolerant patients defined as ≥ 60 morphine equivalents (MEQs) per day within 90 days prior to surgery
  • * Renal impairment defined as a glomerular filtration rate (GFR) \< 30 mL/minute or creatinine \>1.3 mg/dL
  • * Non-English speaking
  • * Non-independent (i.e. requires a caretaker to make medical decisions on their behalf)

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Rush University Medical Center,

Study Record Dates

2025-04-01