Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty

Pain, Acute Clinical Trial

Official title:

Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty: A Double-blinded Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03271151
• Other study ID #: 2017-0655
• Status: Completed
• Phase: Phase 4
• Start date: September 28, 2017
• Est. completion date: February 10, 2021

Study information

• Verified date: March 2022
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: February 10, 2021
• Est. primary completion date: December 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 25 to 75 years

• Planned use of regional anesthesia

• Ability to follow study protocol

• English speaking (Primary outcome obtained via telephone call and secondary outcomes include questionnaires validated in English only)

• Patients planning on being discharged home or to a rehabilitation center that has agreed to participate

Exclusion Criteria:

• Current Use of duloxetine or other SNRIs, SSRIs, MAOIs, Tricyclic antidepressants, triptans (sumatriptan, rizatriptan, naratriptan, eletriptan, almotriptan, frovatriptan), lithium, buspirone, St. John's Wort

• Hepatic insufficiency

o Hepatoxicity is reported as a side effect of duloxetine. "Median time to detection of transaminase elevation was about two months" (package insert 5.2

• Renal insufficiency (ESRD, HD, estimated creatinine clearance < 50 ml/min)

• Severe CRI may impair duloxetine clearance

• CLcr=[(140-age (years)] x weight (kg)x0.85 (for female patients)/[72xserum creatinine (mg/dL)]

• Patients younger than 25 years old and older than 75

• Patients intending to receive general anesthesia

• Allergy or intolerance to one of the study medications

• Patients with an ASA of IV

• Chronic gabapentin/pregabalin use (regular use for longer than 3 months)

• Patients with major prior ipsilateral open knee surgery.

• Chronic opioid use (taking opioids for longer than 3 months)

• However, patients using chronic opioids may enroll in a parallel pilot study entitled 'effect of duloxetine on opioid use after total knee athroplasty among patients exposed to opioids- a pilot study'. The chronic opioid users will be allowed to continue their customary analgesics. The pilot study is otherwise identical to the main study.

• This study will enroll up to 15 chronic opioid users. After that, all chronic opioid users are excluded.

Related Conditions & MeSH terms

• Acute Pain
• Chronic Pain
• Joint Disease
• Joint Diseases
• Pain, Acute
• Pain, Chronic

Intervention

Drug:
• Cymbalta
Duloxetine ("Cymbalta") is a serotonin and norepinephrine dual reuptake inhibitor (SNRI) that is an effective treatment for painful diabetic neuropathy. It is approved for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathy, fibromyalgia, and chronic musculoskeletal pain

Other:
• Placebo
Placebo to compare outcomes against Duloxetine

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Use	Opioid use (measured in cumulative morphine equivalents)	Post-operative day 14
Primary	Pain Scores	Numerical Rating Score pain with movement. Minimum value of 0, maximum value of 10. Higher scores mean more pain and worse outcome.	Post-operative day 14
Secondary	Pain Phenotype	2011 Survey Criteria for Fibromyalgia. Minimum value of 0, and maximum value of 12. A higher score means a worse outcome.	Day of surgery