Chondral Injury of Left Knee, Chondral Injury of Right Knee, Knee Injuries, Knee Ligament Injury, Knee Osteoarthritis, Loose Body Knee, Meniscus Tear, Synovitis of Knee
Conditions
Keywords
Knee Arthroscopy
Brief summary
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.
Interventions
DRUGDronabinol
5mg 2x daily for 7 days
DRUGPlacebo
1 caplet 2x daily for 7 days
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Patient who will undergo arthroscopic surgery of the knee including, but not limited to, * Meniscectomy * Synovectomy * Chondroplasty * Loose body removal
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 * Anticholinergic agents * Benzodiazepines * Central nervous system depressants * Droperidol * Hydroxyzine * Levomepromazine or methotrimeprazine * Monoamine oxidase inhibitors * Ritonavir * Selective serotonin reuptake inhibitors * Sympathomimetics * St. John's Wort * Current diagnosed alcohol or drug abuse * Patients who cannot or will not abide by the medication restrictions listed below Medication restrictions * Participants must agree to abstain from using recreational or medical marijuana products or cannabidiol (CBD) in any form during the treatment period * Participants should not drink alcohol or take other drugs while taking the study drug or hydrocodone/acetaminophen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | up to 7 days post-surgery | Count of number of hydrocodone/acetaminophen tablet consumed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Visual Analog Scale (VAS) | up to 7 days post-surgery | Scored from 0 (no pain) to 10 (worst possible pain) |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.1 - Pain Interference | up to 21 days post-surgery | 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). |
| PROMIS Bank v2.0 - Pain Behavior | up to 21 days post-surgery | 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). |
| PROMIS Bank v2.0 - Physical Function | up to 21 days post-surgery | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVehniah K Tjong, MD
Northwestern Feinberg School of Medicine
Outcome results
None listed