Does Duloxetine Reduce Sub-Acute Pain After Knee Arthroplasty?

Total Knee Arthroplasty Clinical Trial

Official title:

Does Duloxetine Reduce Sub-Acute Pain After Knee Arthroplasty?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02005601
• Other study ID #: 2012-016
• Status: Completed
• Phase: Phase 4
• First received: December 4, 2013
• Last updated: January 29, 2016
• Start date: November 2013
• Est. completion date: August 2015

Study information

• Verified date: July 2015
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: August 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain
• Total Knee Arthroplasty

Intervention

Drug:
• 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.
• 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.

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	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	No
Secondary	Numeric Rating Scale (NRS) Pain Scores at Rest, during Ambulation and while Bending Knee	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 at rest? during ambulation? while bending your knee?	Preoperative, postoperative day (POD) 1, POD 3, POD 14, POD 18-20, 6 weeks after surgery	No