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Impact of 2.5mg of oral Dronabinol daily versus placebo on post-operative opioid consumption on patients aged 18 to 65 years old undergoing 1 to 3 level posterolateral fusion
This is a randomized double-blind clinical trial comparing 2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery versus placebo for patients aged 18 to 65 years old undergoing 1 to 3 level posterolateral fusion. The outcome of interest is post-operative opioid consumption defined as cumulative Morphine Milligram Equivalents at 72 hours after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dronabinol | Experimental | 2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery |
|
| Placebo | Placebo Comparator | Capsule with placebo daily starting with pre-op cocktail and continued twice daily for three days after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dronabinol 2.5mg Cap | Drug | 2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Morphine Milligrams at 72 hours post-operative | Cumulative Morphine Milligrams consumed in-hospital 72 hours after surgery | 72 hours post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Morphine Milligrams at 24 hours post-operative | Cumulative Morphine Milligrams consumed in-hospital 24 hours after surgery | 24 hours post-operative |
| Cumulative Morphine Milligrams at 48 hours post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey L Gum, MD | Norton Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norton Healthcare | Louisville | Kentucky | 40202 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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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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Double-blind Placebo controlled
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Placebo, randomization and blinding will be maintained by the Hospital Pharmacy
| Placebo | Drug | Placebo capsule daily starting with pre-op cocktail and continued twice daily for three days after surgery |
|
|
Cumulative Morphine Milligrams consumed in-hospital 48 hours after surgery
| 48 hours post-operative |
| Worst pain in past 24 hours post-operative | Worst pain in past 24 hours post-op on a scale of 0 to 10, with 0 as no pain and 10 as worst pain imaginable | 24 hours post-operative |
| Worst pain in past 48 hours post-operative | Worst pain in past 48 hours post-op on a scale of 0 to 10, with 0 as no pain and 10 as worst pain imaginable | 48 hours post-operative |
| Worst pain in past 72 hours post-operative | Worst pain in past 72 hours post-op on a scale of 0 to 10, with 0 as no pain and 10 as worst pain imaginable | 72 hours post-operative |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D004304 |
| Dosage Forms |
| D004364 | Pharmaceutical Preparations |