A Phase 4 interventional study of Cymbalta and Placebo in Joint Disease, Pain, Acute and Pain, Chronic, sponsored by Hospital for Special Surgery, New York. Completed at 1 site in United States. Open to participants aged 25 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Hospital for Special Surgery, New York · Phase 4, Interventional, and Treatment
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.
716 studies on the registry are indexed under Joint Diseases; 127 are open to participants now.
This study's enrollment of 160 is above the median of 60 across 473 interventional studies indexed under Joint Diseases.
Browse Joint Diseases studies →Hospital for Special Surgery, New York is the lead sponsor of 226 studies on the registry; 40 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 22 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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)
Chronic opioid use (taking opioids for longer than 3 months)
Epidural analgesia after knee arthroplasty is not as prevalent at HSS as formerly, in large part due to the rise of local infiltration analgesia. Studies using epidural analgesia may also lack generalizability given the infrequent use of epidural analgesia at other institutions. For these reasons, we plan to use adductor canal nerve blockade + local infiltration analgesia for management of immediate postoperative pain. Patients will receive spinal anesthesia as the primary anesthetic. It is particularly important to study duloxetine ("Cymbalta") in the context of local infiltration analgesia, as patients receiving local infiltration analgesia receive increased doses of opioids, compared to patients receiving epidural analgesia.
Drug: Cymbalta
Placebo to compare pain scores and opioid use againts Duloxetine
Other: Placebo
Duloxetine ("Cymbalta") is a serotonin and norepinephrine dual reuptake inhibitor (SNRI) that is an effective treatment for painful diabetic neuropathy. It is approved for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathy, fibromyalgia, and chronic musculoskeletal pain
Placebo to compare outcomes against Duloxetine
Opioid Use
Opioid use (measured in cumulative morphine equivalents)
Time frame: Post-operative day 14
Pain Scores
Numerical Rating Score pain with movement. Minimum value of 0, maximum value of 10. Higher scores mean more pain and worse outcome.
Time frame: Post-operative day 14
Pain Phenotype
2011 Survey Criteria for Fibromyalgia. Minimum value of 0, and maximum value of 12. A higher score means a worse outcome.
Time frame: Day of surgery
| Milestone | Duloxetine ("Cymbalta") | Placebo |
|---|---|---|
| Started | 80 | 80 |
| Completed | 78 | 77 |
| Not completed | 2 | 3 |
| Withdrew: Lost to follow-up | 1 | 3 |
| Withdrew: Withdrawal by subject | 1 | 0 |
Opioid use (measured in cumulative morphine equivalents)
| Oral Morphine Equivalent (mg) | Duloxetine ("Cymbalta") | Placebo |
|---|---|---|
| Opioid Use | 288 ± 226 | 432.5 ± 374 |
Numerical Rating Score pain with movement. Minimum value of 0, maximum value of 10. Higher scores mean more pain and worse outcome.
| score on a scale (NRS) | Duloxetine ("Cymbalta") | Placebo |
|---|---|---|
| Pain Scores | 4.2 ± 2 | 4.8 ± 2.2 |
2011 Survey Criteria for Fibromyalgia. Minimum value of 0, and maximum value of 12. A higher score means a worse outcome.
| score on a scale | Duloxetine ("Cymbalta") | Placebo |
|---|---|---|
| Pain Phenotype | 2 (1 to 4) | 2 (1 to 4) |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Duloxetine ("Cymbalta") | 0/80 (0%) | 0/80 (0%) | 2/80 (2.5%) |
| Placebo | 0/80 (0%) | 0/80 (0%) | 3/80 (3.8%) |
| Event | Duloxetine ("Cymbalta") | Placebo |
|---|---|---|
| HallucinationsGeneral disorders | 1/80 | 1/80 |
| Unable to EjaculateReproductive system and breast disorders | 1/80 | 0/80 |
| Increased diaphoresis, blood pressure, complaints of diarrhea decreased unration and tooth painGeneral disorders | 0/80 | 1/80 |
| AcneGeneral disorders | 0/80 | 1/80 |
| Age, Categorical(Participants) | Duloxetine ("Cymbalta") | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 41 | 42 | 83 |
| >=65 years | 39 | 38 | 77 |
| Age, Continuous(years) | Duloxetine ("Cymbalta") | Placebo | Total |
|---|---|---|---|
| Mean | 63 ± 11 | 64 ± 7 | 63 ± 9 |
| Sex: Female, Male(Participants) | Duloxetine ("Cymbalta") | Placebo | Total |
|---|---|---|---|
| Female | 40 | 35 | 75 |
| Male | 40 | 45 | 85 |
| Ethnicity (NIH/OMB)(Participants) | Duloxetine ("Cymbalta") | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 2 | 6 |
| Not Hispanic or Latino | 76 | 78 | 154 |
| Unknown or Not Reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Sep 2017 to primary completion in Dec 2020, 38 months.
Results were first posted in Apr 2022, 1 year 4 months after primary completion.
Of 21 phase 4 interventional studies under Joint Diseases, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 48. This study's 38 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Duloxetine
Hospital for Special Surgery, New York →