COMPLETED

Duloxetine RCT on Postop TKA Outcomes

Conditions

Pain, Postoperative Total Knee Arthroplasty duloxetine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-11-01

Study Completion:2025-07-23

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05086393

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.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)

Inclusion Criteria

Exclusion 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)

Contacts and Locations

Study Locations (Sites)

Rush University medical Center

Chicago, Illinois, 60612

United States

Collaborators and Investigators

Sponsor: Rush University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-01

Study Completion Date2025-07-23

Study Record Updates

Study Start Date2021-11-01

Study Completion Date2025-07-23

Terms related to this study

Keywords Provided by Researchers

duloxetine

Additional Relevant MeSH Terms

Pain, Postoperative
Total Knee Arthroplasty