MedPath

Does Duloxetine Reduce Sub-Acute Pain After Knee Arthroplasty?

Phase 4
Completed
Conditions
Total Knee Arthroplasty
Interventions
Registration Number
NCT02005601
Lead Sponsor
Hospital for Special Surgery, New York
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
106
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ControlPlaceboPatients will receive 0mg of duloxetine
DuloxetineDuloxetine 60mgPatients 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.
Primary Outcome Measures
NameTimeMethod
NRS Pain With Ambulation at 2 Weeks2 weeks after surgery

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?

Secondary Outcome Measures
NameTimeMethod
Total Daily Opioid Use (mg Oral Morphine Equivalents)POD 1

Total daily opioid use (including PO, PCEA, IV, subcutaneous, IV push) in mg oral morphine equivalents on POD 1.

Nausea SeverityPOD 1

Nausea severity measured using Likert scale ranging from 0 (none) to 10 (severe).

Trial Locations

Locations (1)

Hospital for Special Surgery

🇺🇸

New York, New York, United States

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