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This study is designed to investigate the effect of dronabinol on post operative pain in patients undergoing total knee replacement (for their own clinical care).
Total knee replacement is a common surgical procedure that restores function to the damaged joint. Recovery from this procedure takes weeks and requires opioids to manage post-surgical pain. The goal of this study is to investigate whether dronabinol (synthetic THC) can reduce pain and the need for opioid medication following this particular surgery.
Subjects will be recruited from the Department of Orthopedic Surgery. All subjects will undergo total knee replacement as part of their clinical care (the surgery itself is not part of this study). The study begins following discharge from the hospital. They will be asked to take dronabinol or placebo as they recover from surgery. During this time they will be given their usual pain medications at discharge which includes opioids for pain. The opioids are to be taken if the subject is experiencing pain. The investigator's hypothesis is that subjects taking dronabinol will need fewer doses of opioids to control pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dronabinol | Experimental | active group |
|
| control | Placebo Comparator | control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dronabinol 5mg Cap | Drug | 1 QAM and 2 QHS PO 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory-Short Form | pain assessment, self report measure of pain, scale 0-10 (10 worst) | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| opioid medication log | opioid use by participant for pain after surgery | two weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diana Martinez, MD | NYSPI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1051 Riverside Drive | New York | New York | 10032 | United States |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| D002214 | Capsules |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Non-active comparator |
| Drug |
1 QAM and 2 QHS PO 14 days |
|
| D004304 |
| Dosage Forms |
| D004364 | Pharmaceutical Preparations |