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The purpose of the proposed study is to evaluate the efficacy of dronabinol for postoperative pain after arthroscopic surgery of the knee. The investigators hypothesize that dronabinol will relieve pain, reduce opioid consumption and will result in few negative side effects. If this pilot study shows promising results the investigators will expand the trial to include additional arthroscopic surgeries (hip, shoulder) and other types of orthopaedic surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dronabinol | Experimental | Patients will received dronabinol (5mg) twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery |
|
| Placebo | Placebo Comparator | Patients will received placebo twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dronabinol | Drug | 5mg 2x daily for 7 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption | Count of number of hydrocodone/acetaminophen tablet consumed | up to 7 days post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Visual Analog Scale (VAS) | Scored from 0 (no pain) to 10 (worst possible pain) | up to 7 days post-surgery |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.1 - Pain Interference |
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Inclusion Criteria:
Age 18 years or older
Patient who will undergo arthroscopic surgery of the knee including, but not limited to,
Exclusion Criteria:
Patients under age 18 years
Patients who cannot provide consent
Patients who are pregnant, breast feeding, or are trying to become pregnant during the study period
Patients with an allergy to any of the study drugs
Patient who are lactose-intolerant
Revision surgery
Open surgery
Comorbidities preventing surgery
Patients with a history of mania, depression, or schizophrenia
Patients taking any of the following drugs or supplements
Current diagnosed alcohol or drug abuse
Patients who cannot or will not abide by the medication restrictions listed below
Medication restrictions
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| Name | Affiliation | Role |
|---|---|---|
| Vehniah K Tjong, MD | Northwestern Feinberg School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D007718 | Knee Injuries |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Placebo | Drug | 1 caplet 2x daily for 7 days |
|
PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population (usually U.S. general population). A low score indicates less pain interference (better outcome) and a high score indicates more pain interference (worse outcome).
| up to 21 days post-surgery |
| PROMIS Bank v2.0 - Pain Behavior | PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50. A low score indicates less pain (better outcome) and a high score indicates more pain (worse outcome). | up to 21 days post-surgery |
| PROMIS Bank v2.0 - Physical Function | PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50. A low score indicates worse physical functioning and a high score indicates better physical functioning. | up to 21 days post-surgery |
| D012216 |
| Rheumatic Diseases |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |