NCT03271151

Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty

Completed Phase 4 Results posted Last updated 27 December 2024

What this trial tests

Phase 4 trial testing Cymbalta in Joint Disease in 160 participants. Completed in 19 February 2021.

Timeline

28 September 2017

Primary endpoint
3 December 2020

19 February 2021

Quick facts

Lead sponsor	Hospital for Special Surgery, New York
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	160
Start date	28 September 2017
Primary completion	3 December 2020
Estimated completion	19 February 2021
Sites	1 location across United States

Drugs / interventions tested

• Cymbalta (duloxetine) — full drug profile →
• Placebo

Conditions studied

• Joint Disease — all drugs for Joint Disease →
• Pain, Acute — all drugs for Pain, Acute →
• Pain, Chronic — all drugs for Pain, Chronic →

Sponsor

Hospital for Special Surgery, New York

Who can join

Adults 25 to 75, any sex, with Joint Disease or Pain, Acute. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Opioid Use Primary · Post-operative day 14

Opioid use (measured in cumulative morphine equivalents)

Group	Value	95% CI
Duloxetine ("Cymbalta")	288	± 226
Placebo	432.5	± 374

Pain Scores Primary · Post-operative day 14

Numerical Rating Score pain with movement. Minimum value of 0, maximum value of 10. Higher scores mean more pain and worse outcome.

Group	Value	95% CI
Duloxetine ("Cymbalta")	4.2	± 2
Placebo	4.8	± 2.2

Pain Phenotype Secondary · Day of surgery

2011 Survey Criteria for Fibromyalgia. Minimum value of 0, and maximum value of 12. A higher score means a worse outcome.

Group	Value	95% CI
Duloxetine ("Cymbalta")	2	1 – 4
Placebo	2	1 – 4

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Duloxetine ("Cymbalta")

Serious: 0/80 (0%)

Deaths: 0/80

Placebo

Serious: 0/80 (0%)

Deaths: 0/80

Other adverse events (4 terms — click to expand)

Reaction	System	Duloxetine ("Cymbalta")	Placebo
Hallucinations	General disorders	—	—
Unable to Ejaculate	Reproductive system and breast disorders	—	—
Increased diaphoresis, blood pressure, complaints of diarrhea decreased unration and tooth pain	General disorders	—	—
Acne	General disorders	—	—

Data from ClinicalTrials.gov NCT03271151 adverse events section.

Sponsor's own description

Post-discharge pain after total knee arthroplasty remains problematic; many patients have excessive pain at the 2 week time point (and often thereafter). Reduction in opioid use has become a national goal, due to the 'epidemic' in opioid misuse.

In addition to enrolling non-opioid users, we will enroll up to 15 chronic opioid users.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.