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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duloxetine ("Cymbalta") | Experimental | 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. |
|
| Placebo | Placebo Comparator | Placebo to compare pain scores and opioid use againts Duloxetine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cymbalta | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Use | Opioid use (measured in cumulative morphine equivalents) | 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. | Post-operative day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Phenotype | 2011 Survey Criteria for Fibromyalgia. Minimum value of 0, and maximum value of 12. A higher score means a worse outcome. | Day of surgery |
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Inclusion Criteria:
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)
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)
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| Name | Affiliation | Role |
|---|---|---|
| Jacques T YaDeau, MD, Phd | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Duloxetine ("Cymbalta") | 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. Cymbalta: 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 |
| FG001 | Placebo | Placebo to compare pain scores and opioid use againts Duloxetine Placebo: Placebo to compare outcomes against Duloxetine |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Duloxetine ("Cymbalta") | 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. Cymbalta: 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Opioid Use | Opioid use (measured in cumulative morphine equivalents) | Posted | Mean | Standard Deviation | Oral Morphine Equivalent (mg) | Post-operative day 14 |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Duloxetine ("Cymbalta") | 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. Cymbalta: 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hallucinations | General disorders | Non-systematic Assessment | Patient reported experiencing hallucinations. Unclear if related to study medication and/or opioid |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jacques Yadeau | Anesthesiology Critical Care & Pain Management | 2127742224 | Yadeauj@hss.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 27, 2021 | Mar 29, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D059787 | Acute Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
| Placebo | Other | Placebo to compare outcomes against Duloxetine |
|
| BG001 | Placebo | Placebo to compare pain scores and opioid use againts Duloxetine Placebo: Placebo to compare outcomes against Duloxetine |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Placebo | Placebo to compare pain scores and opioid use againts Duloxetine Placebo: Placebo to compare outcomes against Duloxetine |
|
|
| Primary | Pain Scores | Numerical Rating Score pain with movement. Minimum value of 0, maximum value of 10. Higher scores mean more pain and worse outcome. | Posted | Mean | Standard Deviation | score on a scale (NRS) | Post-operative day 14 |
|
|
|
| Secondary | Pain Phenotype | 2011 Survey Criteria for Fibromyalgia. Minimum value of 0, and maximum value of 12. A higher score means a worse outcome. | Posted | Median | Inter-Quartile Range | score on a scale | Day of surgery |
|
|
|
| 0 |
| 80 |
| 0 |
| 80 |
| 2 |
| 80 |
| EG001 | Placebo | Placebo to compare pain scores and opioid use againts Duloxetine Placebo: Placebo to compare outcomes against Duloxetine | 0 | 80 | 0 | 80 | 3 | 80 |
|
| Unable to Ejaculate | Reproductive system and breast disorders | Non-systematic Assessment | Unclear if related to study medication and/or opioid medication |
|
| Increased diaphoresis, blood pressure, complaints of diarrhea decreased unration and tooth pain | General disorders | Non-systematic Assessment | Not typical duloxetine side effects; unclear if study related |
|
| Acne | General disorders | Non-systematic Assessment | Patient reported acne on chest and back, 14 days after surgery. Unclear if due to study |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |