Phase 4
Completed N=106
Does Duloxetine Reduce Sub-Acute Pain After Knee Arthroplasty?
Source: ClinicalTrials.gov NCT02005601 ↗Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcomePrimary: NRS Pain With Ambulation at 2 Weeks — 3.5; 3.8 NRS pain score
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY NRS Pain With Ambulation at 2 Weeks |
3.5; 3.8 | — |
| SECONDARY Total Daily Opioid Use (mg Oral Morphine Equivalents) |
57.8; 72.7 | — |
| SECONDARY Nausea Severity |
0.9; 2.3 | — |
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
Data sourced from ClinicalTrials.gov (NCT02005601). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.