Does Duloxetine Reduce Sub-Acute Pain After Knee Arthroplasty?

NCT02005601 | Completed Phase 4 Results

• 1 other identifier: 2012-016
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• NRS Pain With Ambulation at 2 Weeks

  When considering the pain in the knee in which you are having/had surgery, on a scale of 0-10, with 0 being no pain and 10 being pain as bad as you can imagine, how would you describe your level of pain in the last 24 hours during ambulation?

  2 weeks after surgery

Secondary Outcomes (2)

• Total Daily Opioid Use (mg Oral Morphine Equivalents)

  POD 1

• Nausea Severity

  POD 1

Study Arms (2)

Duloxetine

EXPERIMENTAL

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.

Drug: Duloxetine 60mg

Control

PLACEBO COMPARATOR

Patients will receive 0mg of duloxetine

Drug: Placebo

Interventions

Placebo 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.

Control

Duloxetine 60mg 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.

Also known as: Cymbalta

Duloxetine

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Interventions

Duloxetine Hydrochloride

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Jacques Yadeau
• Organization: Hospital for Special Surgery

yadeauj@hss.edu

212-606-1206

Study Officials

• Jacques T YaDeau, MD, PhD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 9, 2013
• Study Start: November 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 29, 2017
• Results First Posted: August 29, 2017

Record last verified: 2017-07

Locations

US (1)