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The primary objective of this study is to compare total narcotic intake standardized via milligram morphine equivalents between duloxetine and placebo cohorts after a total hip arthroplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duloxetine group | Experimental | Participants will be in this group for up to 2 hours. |
|
| Placebo group | Placebo Comparator | Participants will be in this group for up to 2 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine | Drug | Participants will come in person and receive a one time 60 mg dose by mouth. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Milligram Morphine Equivalent (MME) | The primary outcome measure was milligram morphine equivalent units to measure pain intensity difference and total pain relief | Up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain as measured by Visual Analog Scale (VAS) | The VAS used for pain assessment consists of a line drawn in the form of a ruler, and numbers from 0 to 10 (with 0 as "no pain" and 10 as "unbearable pain") were asked to score. | Baseline, up to 24 hours, 3 months |
| Musculoskeletal function as measured by SMFA questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victor Hernandez, MD | Contact | 3056895195 | vhh1@miami.edu | |
| Natalia Cruz, MD | Contact | 3056895195 | nxc971@miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Victor Hernandez, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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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 | Participants will come in person and receive a one time 60 mg placebo pill dose by mouth. |
|
The Short Musculoskeletal Function Assessment Questionnaire (SMFA) consists of 34 questions covering the assessment of the patients function and 12 questions related to how bothered patients are by their symptoms. All categories are scored together, totaling between 0-100 percent. The lower the score, the better the subject's function |
| Up to 3 months |
| Hospital Length of stay measured in hours | Hospital Length of stay measured in hours | Up to 96 hours |
| Ambulation distance measured by meters | Ambulation distance measured by meters | Up to 3 months |
| D006571 |
| Heterocyclic Compounds |