Pain, Postoperative
Conditions
Brief summary
This study is designed to evaluate the effects of administering CBD to control post-operative pain in patients undergoing shoulder arthroscopy. Secondly, the purpose will be to evaluate the effectiveness of CBD in comparison with opioid therapy for post-operative pain.
Interventions
DRUGCBD Oral Disintegrating Tablet (ODT)
Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen
OTHERPlacebo ODT
Cohort 2 will not receive CBD; but a visually indistinguishable placebo ODT instead. The resident physician, physician assistant, anesthesiologist, surgeon and study team members will remain blinded. Additionally, all patients will receive a traditional upper extremity interscalene block as per routine.
Sponsors
Orcosa Inc.
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing an arthroscopic shoulder procedure (rotator cuff repair, decompression, labrum repair) * Patients ages 18-75, inclusive * Female patients must be currently practicing effective forms of two types of birth control, which are defined as those, alone or in combination, that result in a low failure rate (less than 1% per year) when used consistently and correctly * Male patients must be using an effective form of contraception
Exclusion criteria
* Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.) * Younger than 18 years of age * Older than 75 years of age * Any patient considered a vulnerable subject: pregnant women or fetuses, children, cognitively impaired adults, prisoners * History of cannabis abuse or dependence * History of coagulation abnormalities and thromboembolic disease or current abnormal coagulation test values * History of stroke or acute coronary syndromes within 3 months before surgery * Abnormal coagulation profile * Renal failure (serum creatinine \> 250 μmol/L \[2.83 mg/dL\]) or liver cirrhosis * Patients with a history of hypersensitivity to Percocet * Patients that have been on pre-operative opioid management for any reason * Patients meeting the DSM-V for major psychiatric illness, such as bipolar disorder * Patients diagnosed with major depression, psychosis, or substance abuse disorder * Patients with current or a history of suicidal ideation * Breastfeeding females * Patients with clinically significant illness, including cardiovascular disorders * Clinically significant lab abnormalities * Abnormal LFTs * Patients with major neurological disorders, such as dementia, Parkinson's disease, cognitive impairment, epilepsy, history of traumatic brain/head injury, or seizures * Patients with moderate (Child-Pugh B) and severe hepatic impairment (Child-Pugh C). * Patients taking moderate or strong inhibitors of CYP3A4 and CYP2C19 (listed below) concomitantly * Patients taking strong CYP3A4 and CYP2C19 inducers (listed below) concomitantly * Patients taking substrates of UTG1A9, UTGB17, CYP2A1, CYP2B6, CYP2C8, CYP2C9 and CYP2C19 (listed below) concomitantly
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Visual Analog Scale (VAS) Score | Hour 24 Post-Surgery | Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable). |
| Nausea Score on VAS Scale | Day 2 Post-Surgery | Any nausea experienced by the patients will be recorded by use of a VAS (0 = no nausea, 10 = worst nausea imaginable). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Consumption | Day 1 Post-Surgery | Consumption based on patient-self-report |
| Number of Completed Doses Out of 3 Maximum Doses/Day | Day 1 Post-Surgery | Based on patient-self-report. |
| Patient Satisfaction Score | Hour 24 Post-Surgery | Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 - CBD CBD Oral Disintegrating Tablet (ODT): Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen | 52 |
| Cohort 2 - Placebo Placebo ODT: Cohort 2 will not receive CBD; but a visually indistinguishable placebo ODT instead.
The resident physician, physician assistant, anesthesiologist, surgeon and study team members will remain blinded. Additionally, all patients will receive a traditional upper extremity interscalene block as per routine. | 47 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Cohort 2 - Placebo | Total | Cohort 1 - CBD |
|---|---|---|---|
| Age, Continuous | 57.1 years STANDARD_DEVIATION 10.1 | 57.65 years STANDARD_DEVIATION 9.45 | 58.2 years STANDARD_DEVIATION 8.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 47 Participants | 99 Participants | 52 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 47 Participants | 99 Participants | 52 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 47 participants | 99 participants | 52 participants |
| Sex: Female, Male Female | 17 Participants | 38 Participants | 21 Participants |
| Sex: Female, Male Male | 30 Participants | 61 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 47 |
| other Total, other adverse events | 4 / 52 | 4 / 47 |
| serious Total, serious adverse events | 0 / 52 | 0 / 47 |
Outcome results
Primary
Nausea Score on VAS Scale
Any nausea experienced by the patients will be recorded by use of a VAS (0 = no nausea, 10 = worst nausea imaginable).
Time frame: Day 2 Post-Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 - CBD | Nausea Score on VAS Scale | 2.1 score on a scale | Standard Deviation 2.6 |
| Cohort 2 - Placebo | Nausea Score on VAS Scale | 2.5 score on a scale | Standard Deviation 3.1 |
Primary
Nausea Score on VAS Scale
Any nausea experienced by the patients will be recorded by use of a VAS (0 = no nausea, 10 = worst nausea imaginable).
Time frame: Day 14 Post-Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 - CBD | Nausea Score on VAS Scale | 0.1 score on a scale | Standard Deviation 0.4 |
| Cohort 2 - Placebo | Nausea Score on VAS Scale | 0.5 score on a scale | Standard Deviation 1.7 |
Primary
Nausea Score on VAS Scale
Any nausea experienced by the patients will be recorded by use of a VAS (0 = no nausea, 10 = worst nausea imaginable).
Time frame: Day 7 Post-Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 - CBD | Nausea Score on VAS Scale | 0.2 score on a scale | Standard Deviation 1.1 |
| Cohort 2 - Placebo | Nausea Score on VAS Scale | 0.6 score on a scale | Standard Deviation 2.1 |
Primary
Pain Visual Analog Scale (VAS) Score
Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).
Time frame: Hour 24 Post-Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 - CBD | Pain Visual Analog Scale (VAS) Score | 4.4 score on a scale | Standard Deviation 3.1 |
| Cohort 2 - Placebo | Pain Visual Analog Scale (VAS) Score | 5.7 score on a scale | Standard Deviation 3.2 |
Primary
Pain Visual Analog Scale (VAS) Score
Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).
Time frame: Day 7 Post-Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 - CBD | Pain Visual Analog Scale (VAS) Score | 2.5 score on a scale | Standard Deviation 1.9 |
| Cohort 2 - Placebo | Pain Visual Analog Scale (VAS) Score | 3.2 score on a scale | Standard Deviation 2.7 |
Primary
Pain Visual Analog Scale (VAS) Score
Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).
Time frame: Day 14 Post-Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 - CBD | Pain Visual Analog Scale (VAS) Score | 1.6 score on a scale | Standard Deviation 1.4 |
| Cohort 2 - Placebo | Pain Visual Analog Scale (VAS) Score | 2.3 score on a scale | Standard Deviation 2.4 |
Primary
Pain Visual Analog Scale (VAS) Score
Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).
Time frame: Day 2 Post-Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 - CBD | Pain Visual Analog Scale (VAS) Score | 4.7 score on a scale | Standard Deviation 2.8 |
| Cohort 2 - Placebo | Pain Visual Analog Scale (VAS) Score | 5.3 score on a scale | Standard Deviation 2.6 |
Secondary
Number of Completed Doses Out of 3 Maximum Doses/Day
Based on patient-self-report.
Time frame: Day 7 Post-Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 - CBD | Number of Completed Doses Out of 3 Maximum Doses/Day | 3 Doses | Standard Deviation 0 |
| Cohort 2 - Placebo | Number of Completed Doses Out of 3 Maximum Doses/Day | 2.7 Doses | Standard Deviation 0.95 |
Secondary
Number of Completed Doses Out of 3 Maximum Doses/Day
Based on patient-self-report.
Time frame: Day 14 Post-Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 - CBD | Number of Completed Doses Out of 3 Maximum Doses/Day | 2.8 Doses | Standard Deviation 0.4 |
| Cohort 2 - Placebo | Number of Completed Doses Out of 3 Maximum Doses/Day | 2.7 Doses | Standard Deviation 1 |
Secondary
Number of Completed Doses Out of 3 Maximum Doses/Day
Based on patient-self-report.
Time frame: Day 1 Post-Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 - CBD | Number of Completed Doses Out of 3 Maximum Doses/Day | 2.9 Doses | Standard Deviation 0.27 |
| Cohort 2 - Placebo | Number of Completed Doses Out of 3 Maximum Doses/Day | 3 Doses | Standard Deviation 0 |
Secondary
Patient Satisfaction Score
Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).
Time frame: Day 7 Post-Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 - CBD | Patient Satisfaction Score | 8 score on a scale | Standard Deviation 2.6 |
| Cohort 2 - Placebo | Patient Satisfaction Score | 7.9 score on a scale | Standard Deviation 2.7 |
Secondary
Patient Satisfaction Score
Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).
Time frame: Day 14 Post-Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 - CBD | Patient Satisfaction Score | 8.7 score on a scale | Standard Deviation 2.3 |
| Cohort 2 - Placebo | Patient Satisfaction Score | 8.5 score on a scale | Standard Deviation 2.4 |
Secondary
Patient Satisfaction Score
Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).
Time frame: Hour 24 Post-Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 - CBD | Patient Satisfaction Score | 7 score on a scale | Standard Deviation 3 |
| Cohort 2 - Placebo | Patient Satisfaction Score | 5.6 score on a scale | Standard Deviation 3.7 |
Secondary
Patient Satisfaction Score
Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).
Time frame: Day 2 Post-Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 - CBD | Patient Satisfaction Score | 7.3 score on a scale | Standard Deviation 2.5 |
| Cohort 2 - Placebo | Patient Satisfaction Score | 6 score on a scale | Standard Deviation 3.3 |
Secondary
Total Opioid Consumption
Consumption based on patient-self-report.
Time frame: Day 14 Post-Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 - CBD | Total Opioid Consumption | 8 morphine milligram equivalent (MME) | Standard Deviation 19.3 |
| Cohort 2 - Placebo | Total Opioid Consumption | 10.3 morphine milligram equivalent (MME) | Standard Deviation 22.7 |
Secondary
Total Opioid Consumption
Consumption based on patient-self-report.
Time frame: Day 7 Post-Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 - CBD | Total Opioid Consumption | 59.3 morphine milligram equivalent (MME) | Standard Deviation 53.2 |
| Cohort 2 - Placebo | Total Opioid Consumption | 67.3 morphine milligram equivalent (MME) | Standard Deviation 55.2 |
Secondary
Total Opioid Consumption
Consumption based on patient-self-report
Time frame: Day 1 Post-Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 - CBD | Total Opioid Consumption | 15.2 morphine milligram equivalent (MME) | Standard Deviation 12 |
| Cohort 2 - Placebo | Total Opioid Consumption | 19.7 morphine milligram equivalent (MME) | Standard Deviation 13.6 |
Secondary
Total Opioid Consumption
Consumption based on patient-self-report.
Time frame: Day 2 Post-Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 - CBD | Total Opioid Consumption | 10.3 morphine milligram equivalent (MME) | Standard Deviation 18.7 |
| Cohort 2 - Placebo | Total Opioid Consumption | 16.7 morphine milligram equivalent (MME) | Standard Deviation 36.6 |