Phase 4
N=160
Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty
Joint Disease · Pain, Acute · Pain, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT03271151 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Opioid Use — 288; 432.5 Oral Morphine Equivalent (mg)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Cymbalta (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Use |
288; 432.5 | — |
| PRIMARY Pain Scores |
4.2; 4.8 | — |
| SECONDARY Pain Phenotype |
2; 2 | — |
Summary
Post-discharge pain after total knee arthroplasty remains problematic; many patients have excessive pain at the 2 week time point (and often thereafter). Reduction in opioid use has become a national goal, due to the 'epidemic' in opioid misuse.
In addition to enrolling non-opioid users, we will enroll up to 15 chronic opioid users.
Eligibility Criteria
Inclusion Criteria
- 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
- Current Use of duloxetine or other SNRIs, SSRIs, MAOIs, Tricyclic antidepressants, triptans (sumatriptan, rizatriptan, naratriptan, eletriptan, almotriptan, frovatriptan), lithium, buspirone, St. John's Wort
- Hepatic insufficiency
o Hepatoxicity is reported as a side effect of duloxetine. "Median time to detection of transaminase elevation was about two months" (package insert 5.2
- Renal insufficiency (ESRD, HD, estimated creatinine clearance < 50 ml/min)
- Severe CRI may impair duloxetine clearance
- CLcr=[(140-age (years)] x weight (kg)x0.85 (for female patients)/[72xserum creatinine (mg/dL)]
- 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)
- Patients with major prior ipsilateral open knee surgery.
- Chronic opioid use (taking opioids for longer than 3 months)
- However, patients using chronic opioids may enroll in a parallel pilot study entitled 'effect of duloxetine on opioid use after total knee athroplasty among patients exposed to opioids- a pilot study'. The chronic opioid users will be allowed to continue their customary analgesics. The pilot study is otherwise identical to the main study.
- This study will enroll up to 15 chronic opioid users. After that, all chronic opioid users are excluded.
Data sourced from ClinicalTrials.gov (NCT03271151). 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.