Does Duloxetine Reduce Sub-Acute Pain After Knee Arthroplasty?

NCT ID: NCT02005601

Last Updated: 2017-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-08-31

Brief Summary

We are investigating the impact of duloxetine ("Cymbalta"), a serotonin and norepinephrine reuptake inhibitor, on pain after total knee arthroplasty (TKA). Specifically, the investigators will determine whether duloxetine, 60 mg daily for 2 weeks, reduces pain scores 2 weeks after TKA.

Conditions

Total Knee Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Duloxetine

Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.

Group Type: EXPERIMENTAL

Duloxetine 60mg

Intervention Type: DRUG

Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.

Control

Patients will receive 0mg of duloxetine

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.

Interventions

Placebo

Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.

Intervention Type: DRUG

Duloxetine 60mg

Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.

Intervention Type: DRUG

Other Intervention Names

Cymbalta

Eligibility Criteria

Inclusion Criteria

• Patients with osteoarthritis scheduled for primary tricompartmental total knee arthroplasty with a participating surgeon
• 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

• Concurrent use of duloxetine or other SNRIs, MAOIs, Tricyclic antidepressants, triptans (sumatriptan, rizatriptan, naratriptan, zolmitriptan, eletriptan, almotriptan, frovatriptan), lithium, buspirone, St. John's Wort
• Hepatic insufficiency
• Renal insufficiency
• 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)
• Chronic opioid use (taking opioids for longer than 3 months)
• Patients with major prior ipsilateral open knee surgery

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques T YaDeau, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

Hospital for Special Surgery

New York, New York, United States

Countries

United States

Other Identifiers

2012-016

Identifier Type: -

Identifier Source: org_study_id