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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duloxetine | Experimental | Patients 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. |
|
| Control | Placebo Comparator | Patients will receive 0mg of duloxetine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14. |
|
| Measure | Description | Time Frame |
|---|---|---|
| NRS Pain With Ambulation at 2 Weeks | 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? | 2 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Total Daily Opioid Use (mg Oral Morphine Equivalents) | Total daily opioid use (including PO, PCEA, IV, subcutaneous, IV push) in mg oral morphine equivalents on POD 1. | POD 1 |
| Nausea Severity | Nausea severity measured using Likert scale ranging from 0 (none) to 10 (severe). |
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Inclusion Criteria:
Exclusion Criteria:
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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 | Patients 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. Duloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14. |
| FG001 | Control | Patients will receive 0mg of duloxetine Placebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Duloxetine | Patients 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. Duloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | NRS Pain With Ambulation at 2 Weeks | 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? | Posted | Mean | Standard Deviation | NRS pain score | 2 weeks after surgery |
|
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 | Patients 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. Duloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | Other | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jacques Yadeau | Hospital for Special Surgery | 212-606-1206 | yadeauj@hss.edu |
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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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| Duloxetine 60mg | Drug | Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14. |
|
|
| POD 1 |
| BG001 |
| Control |
Patients will receive 0mg of duloxetine Placebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Median | Inter-Quartile Range | kg/m^2 |
|
| Knee pain severity with ambulation | Knee pain severity assessed on Numeric Pain Rating scale, which range from 0 (no pain) to 10 (worst pain) | Mean | Standard Deviation | Units on a scale |
|
Patients will receive 0mg of duloxetine
Placebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.
|
|
| Secondary | Total Daily Opioid Use (mg Oral Morphine Equivalents) | Total daily opioid use (including PO, PCEA, IV, subcutaneous, IV push) in mg oral morphine equivalents on POD 1. | Posted | Mean | Standard Deviation | mg oral morphine equivalents | POD 1 |
|
|
|
| Secondary | Nausea Severity | Nausea severity measured using Likert scale ranging from 0 (none) to 10 (severe). | Posted | Mean | Standard Deviation | units on a scale | POD 1 |
|
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| 4 |
| 53 |
| EG001 | Control | Patients will receive 0mg of duloxetine Placebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14. | 0 | 53 | 0 | 53 | 3 | 53 |
| Nausea | General disorders | Other | Non-systematic Assessment |
|
| Headache | General disorders | Other | Non-systematic Assessment |
|
| Somnolence | General disorders | Other | Non-systematic Assessment |
|
| SIADH | Endocrine disorders | Other | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Other | Non-systematic Assessment |
|
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| D006571 |
| Heterocyclic Compounds |