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| Name | Class |
|---|---|
| Orcosa Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - CBD | Experimental |
| |
| Cohort 2 - Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBD Oral Disintegrating Tablet (ODT) | Drug | Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Hour 24 Post-Surgery |
| 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). | Day 2 Post-Surgery |
| 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). | Day 7 Post-Surgery |
| 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). | Day 14 Post-Surgery |
| 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). | Day 2 Post-Surgery |
| 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). | Day 7 Post-Surgery |
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Consumption | Consumption based on patient-self-report | Day 1 Post-Surgery |
| Total Opioid Consumption | Consumption based on patient-self-report. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Michael Alaia, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38322981 | Derived | Alaia MJ, Li ZI, Chalem I, Hurley ET, Vasavada K, Gonzalez-Lomas G, Rokito AS, Jazrawi LM, Kaplan K. Cannabidiol for Postoperative Pain Control After Arthroscopic Rotator Cuff Repair Demonstrates No Deficits in Patient-Reported Outcomes Versus Placebo: 1-Year Follow-up of a Randomized Controlled Trial. Orthop J Sports Med. 2024 Feb 5;12(2):23259671231222265. doi: 10.1177/23259671231222265. eCollection 2024 Feb. | |
| 35905305 |
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The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to the PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 - CBD | CBD Oral Disintegrating Tablet (ODT): Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 - CBD | CBD Oral Disintegrating Tablet (ODT): Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | score on a scale | Hour 24 Post-Surgery |
|
2 weeks
Regular laboratory testing for elevated liver enzymes and self-reporting by participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 - CBD | CBD Oral Disintegrating Tablet (ODT): Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated alanine transaminase | Hepatobiliary disorders | Systematic Assessment | Elevated alanine transaminase at Day 7. All resolved postoperatively by Day 14. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael J. Alaia, MD | NYU Langone Health | (646) 501-7223 | Michael.Alaia@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 5, 2022 | Feb 7, 2023 | Prot_SAP_000.pdf |
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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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| Placebo ODT | Other | 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. |
|
| Day 14 Post-Surgery |
| Day 2 Post-Surgery |
| Total Opioid Consumption | Consumption based on patient-self-report. | Day 7 Post-Surgery |
| Total Opioid Consumption | Consumption based on patient-self-report. | Day 14 Post-Surgery |
| Number of Completed Doses Out of 3 Maximum Doses/Day | Based on patient-self-report. | Day 1 Post-Surgery |
| Number of Completed Doses Out of 3 Maximum Doses/Day | Based on patient-self-report. | Day 7 Post-Surgery |
| Number of Completed Doses Out of 3 Maximum Doses/Day | Based on patient-self-report. | Day 14 Post-Surgery |
| 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). | Hour 24 Post-Surgery |
| 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). | Day 2 Post-Surgery |
| 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). | Day 7 Post-Surgery |
| 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). | Day 14 Post-Surgery |
| Derived |
| Alaia MJ, Hurley ET, Vasavada K, Markus DH, Britton B, Gonzalez-Lomas G, Rokito AS, Jazrawi LM, Kaplan K. Buccally Absorbed Cannabidiol Shows Significantly Superior Pain Control and Improved Satisfaction Immediately After Arthroscopic Rotator Cuff Repair: A Placebo-Controlled, Double-Blinded, Randomized Trial. Am J Sports Med. 2022 Sep;50(11):3056-3063. doi: 10.1177/03635465221109573. Epub 2022 Jul 29. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | Day 2 Post-Surgery |
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | Day 7 Post-Surgery |
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | Day 14 Post-Surgery |
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | Day 2 Post-Surgery |
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | Day 7 Post-Surgery |
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | Day 14 Post-Surgery |
|
|
|
| Secondary | Total Opioid Consumption | Consumption based on patient-self-report | Posted | Mean | Standard Deviation | morphine milligram equivalent (MME) | Day 1 Post-Surgery |
|
|
|
| Secondary | Total Opioid Consumption | Consumption based on patient-self-report. | Posted | Mean | Standard Deviation | morphine milligram equivalent (MME) | Day 2 Post-Surgery |
|
|
|
| Secondary | Total Opioid Consumption | Consumption based on patient-self-report. | Posted | Mean | Standard Deviation | morphine milligram equivalent (MME) | Day 7 Post-Surgery |
|
|
|
| Secondary | Total Opioid Consumption | Consumption based on patient-self-report. | Posted | Mean | Standard Deviation | morphine milligram equivalent (MME) | Day 14 Post-Surgery |
|
|
|
| Secondary | Number of Completed Doses Out of 3 Maximum Doses/Day | Based on patient-self-report. | Posted | Mean | Standard Deviation | Doses | Day 1 Post-Surgery |
|
|
|
| Secondary | Number of Completed Doses Out of 3 Maximum Doses/Day | Based on patient-self-report. | Posted | Mean | Standard Deviation | Doses | Day 7 Post-Surgery |
|
|
|
| Secondary | Number of Completed Doses Out of 3 Maximum Doses/Day | Based on patient-self-report. | Posted | Mean | Standard Deviation | Doses | Day 14 Post-Surgery |
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | Hour 24 Post-Surgery |
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | Day 2 Post-Surgery |
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | Day 7 Post-Surgery |
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | Day 14 Post-Surgery |
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 4 |
| 52 |
| EG001 | 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. | 0 | 47 | 0 | 47 | 4 | 47 |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |