Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In light of the opioid epidemic and evidence suggesting that cannabis may be opioid-sparing, we are in a unique position to conduct a novel, high-impact study that would set the stage for future RCTs examining the effects of a nonintoxicating and nonaddictive cannabinoid in an orthopedic patient population. Epidiolex®, an oral cannabidiol (CBD) solution, is the first ever cannabis-derived medication to be approved by the Food & Drug Administration. Our aim is to conduct a pilot study using a placebo oral solution, 400mg and 800mg Epidiolex® to gather data on its effects on patients undergoing bilateral total knee arthroplasty (BTKA). We will be estimating whether Epidiolex® is associated with minimal opioid use and adequate analgesia. We will also assess its tolerability, pharmacokinetics, and effects on inflammatory markers in the perioperative setting.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ora-sweet SF | Placebo Comparator |
| |
| 400mg cannabidiol | Experimental |
| |
| 800mg cannabidiol | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cannabidiol | Drug | Epidiolex (cannabidiol) oral solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Opioid Usage in First 72 Hours Postoperatively | Cumulative opioid usage over the first 72 hours after surgery. Measured in morphine equivalents (ME), a scale that measure opioid usage among all opioid medications | 0-72 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of CBD | Levels of CBD in the blood. This is measured using blood draws and lab analysis. | 0, 1, 2, 3, 4, 6 hours after medication administration |
| Levels of Plasma Inflammatory Marker Interleukin-6 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alexandra Sideris, PhD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
Beginning 9 months and ending 36 months following article publication
For researchers who provide a methodologically sound proposal and analyses to achieve aims in the approved proposal. Proposals should be directed to siderisa@hss.edu. To gain access, data requestors will need to sign a data access agreement.
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ora-sweet SF | Ora-sweet SF: Ora-sweet SF placebo |
| FG001 | 400mg Cannabidiol | cannabidiol: Epidiolex (cannabidiol) oral solution |
| FG002 | 800mg Cannabidiol | cannabidiol: Epidiolex (cannabidiol) oral solution |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One participant in the Ora-sweet SF group was not included in the baseline characteristics count due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ora-sweet SF | Ora-sweet SF: Ora-sweet SF placebo |
| BG001 | 400mg Cannabidiol | cannabidiol: Epidiolex (cannabidiol) oral solution |
| 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 | Cumulative Opioid Usage in First 72 Hours Postoperatively | Cumulative opioid usage over the first 72 hours after surgery. Measured in morphine equivalents (ME), a scale that measure opioid usage among all opioid medications | One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis. | Posted | Mean | Standard Deviation | Morphine Milligram Equivalents (MME) | 0-72 hours postoperatively |
|
Adverse event data were collected via systematic assessment through postoperative day 7 and at 3 months postoperatively.
One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ora-sweet SF | Ora-sweet SF: Ora-sweet SF placebo | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small Bowel Obstruction | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyponatremia | Blood and lymphatic system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexandra Sideris | Hospital for Special Surgery | 212.774.2602 | siderisa@hss.edu |
Not provided
| 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 | Dec 5, 2025 | Dec 5, 2025 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ora-sweet SF | Other | Ora-sweet SF placebo |
|
Interleukin-6 (IL6) is an inflammatory marker found in plasma. The levels of IL6 are measured using blood draws and lab analysis.
The outcome measure below indicates the difference between IL6 levels on postoperative day 1 and preoperative.
| Preoperative, Postoperative day 1 |
| NRS Pain at Rest | Pain at rest measured using numerical rating scale(NRS) from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable. | Preoperatively; postoperatively in the PACU, morning of postoperative day (POD) 1,2,3,4,7 and at 3 months |
| NRS Pain With Movement | Pain with movement using numerical rating scale(NRS) from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable. | Preoperatively; morning of postoperative day (POD) 1,2,3,4,7 and at 3 months |
| Brief Pain Inventory Short Form | Brief Pain inventory short form measures the severity of pain and its impact on function. It measures pain from 0-10 0 being no pain whatsoever to 10 being the worst pain imaginable. It measures impact on function from 0-10, 0 being no impact whatsoever to 10 being completely impactful. | Preoperatively; morning of postoperative day (POD) 1,2,3,4,7 and at 3 months |
| Incidence of Adverse Events | Adverse events, including allergic reactions, pyrexia (fever), somnolence (excessive sleepiness), GI problems (upset stomach, diarrhea), dry mouth, escalation of post-operative opioid requirement | Postoperatively in the PACU; morning of postoperative day (POD) 1,2,3,4,7 and at 3 months |
| Opioid Related Symptom Distress Scale (ORSDS) | Opioid related Symptom Distress Scale (ORSDS) measures opioid related side effects. There are 12 side effects with 3 subcategories (severity, frequency, bothersomeness) each with 5 different responses (scored 0-4 with higher scores indicating worse symptoms). The ORSDS composite score was calculated by averaging the scores for each symptom. | Morning of postoperative day (POD) 1,2,3,4,7 and at 3 months |
| Anxiety Levels | Hospital Anxiety and Depression Scale (HADS) asks 14 questions, 7 about anxiety and 7 about depression. Responses are scored from 0-3. Responses between the two categories are summed and scoring is as follows: 0-7 = normal, 8-10=borderlines abnormal, 11-21=abnormal | Preoperatively; Morning of postoperative day (POD) 1,2,3,4,7 and at 3 months |
| Cumulative Inpatient Analgesic Use (Non-opioid) | Total non-opioid medication usage | POD0 - POD3 |
| Number of Participants With Opioid and Non-opioid Medication Use | Opioid and non-opioid medication use by count (%) | POD0 - POD3 |
| Opioid & Non-opioid Analgesic Consumption | Total opioid (morphine milligram equivalents) & non-opioid medication usage | At hospital discharge to POD7 |
| Number of Participants With Opioid and Non-opioid Medication Use | Opioid & non-opioid medication use by count (%) | POD0 to POD7 and 3 months |
| Hospital Length of Stay | Length of stay measured in hours from end of surgery to hospital discharge | At hospital discharge |
| Blinding Assessment | Patients are asked which treatment they think they received. The correctness of their guesses is then measured using the bang-blinding index to see if patients were able to accurately guess which treatment they received. It is measured on a scale of -1 to 1. Scores closer to 0 indicate better blinding, or patients not being able to guess their treatment. The index (number) is calculated as a group-level summary statistic, computed from the distribution of guesses across all participants in a group. | POD4 |
| Time to Reach Discharge Physical Therapy Goals | Physical therapy goals for total knee replacement include walking 100 feet, going up and down 4 stairs, and independent transfer (meaning they can move from a lying to standing position independently). Patients need to complete these goals before being discharged | At hospital discharge |
| Range of Motion | Range of motion, or extension and flexion of the knees, are measured preoperatively and at the patients' 6 week surgeon visit. It is measured in degrees | preoperatively, 6 weeks postoperatively. |
| Actigraphy Sleep Efficiency | Sleep quality assessed by actigraphy using ActiGraph wGT3X-BT activity monitor. Higher sleep efficiency indicates better sleep quality. Sleep efficiency was calculated between the hours of 11pm and 6am each night. | POD0 - POD3 |
| Actigraphy Sleep Time | Sleep quality assessed by actigraphy using ActiGraph wGT3X-BT activity monitor. Higher sleep time indicates better sleep quality. Total sleep time was calculated between the hours of 11pm and 6am each night. | POD0 - POD3 |
| Sleep Quality | Sleep quality assessed by Leeds sleep evaluation questionnaire (LSEQ). Responses to 10 questions will be measured on a slider scale ranging from 0-100. Higher scores indicate better outcomes. Getting to Sleep domain scores were calculated by averaging the responses to Questions 1-3 regarding falling asleep. Quality of Sleep domain scores were calculated by averaging the responses to Questions 4-5 regarding quality of sleep. Awake Following Sleep domain scores were calculated by averaging the responses to Questions 6-7 regarding awakening from sleep. Behaviour Following Wakening domain scores were calculated by averaging the responses to Questions 8-10 regarding feeling, balance, and coordination upon awakening. | preoperatively; morning of postoperative day (POD) 1,2,3,4,7 and at 3 months |
| Screen fail after enrollment |
|
| Discontinued intervention |
|
| BG002 | 800mg Cannabidiol | cannabidiol: Epidiolex (cannabidiol) oral solution |
| BG003 | 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 |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Height | Mean | Standard Deviation | centimeters |
|
| ASA Status | The American Society of Anesthesiologists (ASA) Physical Status Classification System is a standardized method of evaluating patient's medical comorbidities to estimate/predict perioperative risk. Hendrix and Garmon define each status from ASA 1 to ASA 6 with examples. Higher ASA Status indicates greater comorbidity burden and perioperative risk. Hendrix JM, Garmon EH. American Society of Anesthesiologists Physical Status Classification System. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan. 2025 Feb 11. Accessed 2026 Jan. | Count of Participants | Participants |
|
| OG002 | 800mg Cannabidiol | cannabidiol: Epidiolex (cannabidiol) oral solution |
|
|
| Secondary | Pharmacokinetics of CBD | Levels of CBD in the blood. This is measured using blood draws and lab analysis. | Reasons for discrepancy between analyzed and overall number analyzed: missed sample collection, missed during lab analysis One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis. | Posted | Mean | Standard Deviation | micromolar | 0, 1, 2, 3, 4, 6 hours after medication administration |
|
|
|
| Secondary | Levels of Plasma Inflammatory Marker Interleukin-6 | Interleukin-6 (IL6) is an inflammatory marker found in plasma. The levels of IL6 are measured using blood draws and lab analysis. The outcome measure below indicates the difference between IL6 levels on postoperative day 1 and preoperative. | One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis. | Posted | Mean | Standard Deviation | picograms per milliliter | Preoperative, Postoperative day 1 |
|
|
|
| Secondary | NRS Pain at Rest | Pain at rest measured using numerical rating scale(NRS) from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable. | Reasons for discrepancy between analyzed and overall number analyzed: withdrawn or lost to follow-up, missed data collection One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis. | Posted | Median | Inter-Quartile Range | scores on a scale | Preoperatively; postoperatively in the PACU, morning of postoperative day (POD) 1,2,3,4,7 and at 3 months |
|
|
|
| Secondary | NRS Pain With Movement | Pain with movement using numerical rating scale(NRS) from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable. | Reasons for discrepancy between analyzed and overall number analyzed: withdrawn or lost to follow-up, missed data collection, specific movement not performed by participant(s) One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis. | Posted | Median | Inter-Quartile Range | score on a scale | Preoperatively; morning of postoperative day (POD) 1,2,3,4,7 and at 3 months |
|
|
|
| Secondary | Brief Pain Inventory Short Form | Brief Pain inventory short form measures the severity of pain and its impact on function. It measures pain from 0-10 0 being no pain whatsoever to 10 being the worst pain imaginable. It measures impact on function from 0-10, 0 being no impact whatsoever to 10 being completely impactful. | Reasons for discrepancy between analyzed and overall number analyzed: withdrawn or lost to follow-up, missed data collection One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis. | Posted | Median | Inter-Quartile Range | units on a scale | Preoperatively; morning of postoperative day (POD) 1,2,3,4,7 and at 3 months |
|
|
|
| Secondary | Incidence of Adverse Events | Adverse events, including allergic reactions, pyrexia (fever), somnolence (excessive sleepiness), GI problems (upset stomach, diarrhea), dry mouth, escalation of post-operative opioid requirement | One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis. Reasons for discrepancy between analyzed and overall number analyzed: withdrawn or lost to follow-up, missed data collection | Posted | Count of Participants | Participants | Postoperatively in the PACU; morning of postoperative day (POD) 1,2,3,4,7 and at 3 months |
|
|
|
| Secondary | Opioid Related Symptom Distress Scale (ORSDS) | Opioid related Symptom Distress Scale (ORSDS) measures opioid related side effects. There are 12 side effects with 3 subcategories (severity, frequency, bothersomeness) each with 5 different responses (scored 0-4 with higher scores indicating worse symptoms). The ORSDS composite score was calculated by averaging the scores for each symptom. | Reasons for discrepancy between analyzed and overall number analyzed: withdrawn or lost to follow-up, missed data collection One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis. | Posted | Median | Inter-Quartile Range | score on a scale | Morning of postoperative day (POD) 1,2,3,4,7 and at 3 months |
|
|
|
| Secondary | Anxiety Levels | Hospital Anxiety and Depression Scale (HADS) asks 14 questions, 7 about anxiety and 7 about depression. Responses are scored from 0-3. Responses between the two categories are summed and scoring is as follows: 0-7 = normal, 8-10=borderlines abnormal, 11-21=abnormal | Reasons for discrepancy between analyzed and overall number analyzed: withdrawn or lost to follow-up, missed data collection One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis. | Posted | Median | Inter-Quartile Range | score on a scale | Preoperatively; Morning of postoperative day (POD) 1,2,3,4,7 and at 3 months |
|
|
|
| Secondary | Cumulative Inpatient Analgesic Use (Non-opioid) | Total non-opioid medication usage | One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis. | Posted | Mean | Standard Deviation | milligrams | POD0 - POD3 |
|
|
|
| Secondary | Number of Participants With Opioid and Non-opioid Medication Use | Opioid and non-opioid medication use by count (%) | One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis. | Posted | Count of Participants | Participants | POD0 - POD3 |
|
|
|
| Secondary | Opioid & Non-opioid Analgesic Consumption | Total opioid (morphine milligram equivalents) & non-opioid medication usage | Reasons for discrepancy between analyzed and overall number analyzed: withdrawn or lost to follow-up One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis. | Posted | Mean | Standard Deviation | milligrams | At hospital discharge to POD7 |
|
|
|
| Secondary | Number of Participants With Opioid and Non-opioid Medication Use | Opioid & non-opioid medication use by count (%) | Reasons for discrepancy between analyzed and overall number analyzed: withdrawn or lost to follow-up One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis. | Posted | Count of Participants | Participants | POD0 to POD7 and 3 months |
|
|
|
| Secondary | Hospital Length of Stay | Length of stay measured in hours from end of surgery to hospital discharge | One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis. | Posted | Median | Inter-Quartile Range | hours | At hospital discharge |
|
|
|
| Secondary | Blinding Assessment | Patients are asked which treatment they think they received. The correctness of their guesses is then measured using the bang-blinding index to see if patients were able to accurately guess which treatment they received. It is measured on a scale of -1 to 1. Scores closer to 0 indicate better blinding, or patients not being able to guess their treatment. The index (number) is calculated as a group-level summary statistic, computed from the distribution of guesses across all participants in a group. | One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis. | Posted | Number | 95% Confidence Interval | score on a scale | POD4 |
|
|
|
| Secondary | Time to Reach Discharge Physical Therapy Goals | Physical therapy goals for total knee replacement include walking 100 feet, going up and down 4 stairs, and independent transfer (meaning they can move from a lying to standing position independently). Patients need to complete these goals before being discharged | Reasons for discrepancy between analyzed and overall number analyzed: study physical therapy goals not completed prior to discharge One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis. | Posted | Median | Inter-Quartile Range | hours | At hospital discharge |
|
|
|
| Secondary | Range of Motion | Range of motion, or extension and flexion of the knees, are measured preoperatively and at the patients' 6 week surgeon visit. It is measured in degrees | Reasons for discrepancy between analyzed and overall number analyzed: range of motion data not found One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis. | Posted | Median | Inter-Quartile Range | degrees | preoperatively, 6 weeks postoperatively. |
|
|
|
| Secondary | Actigraphy Sleep Efficiency | Sleep quality assessed by actigraphy using ActiGraph wGT3X-BT activity monitor. Higher sleep efficiency indicates better sleep quality. Sleep efficiency was calculated between the hours of 11pm and 6am each night. | Reasons for discrepancy between analyzed and overall number analyzed: patients discharged and activity monitors returned prior to data collection One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis. | Posted | Median | Inter-Quartile Range | percent | POD0 - POD3 |
|
|
|
| Secondary | Actigraphy Sleep Time | Sleep quality assessed by actigraphy using ActiGraph wGT3X-BT activity monitor. Higher sleep time indicates better sleep quality. Total sleep time was calculated between the hours of 11pm and 6am each night. | Reasons for discrepancy between analyzed and overall number analyzed: patients discharged and activity monitors returned prior to data collection One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis. | Posted | Median | Inter-Quartile Range | minutes | POD0 - POD3 |
|
|
|
| Secondary | Sleep Quality | Sleep quality assessed by Leeds sleep evaluation questionnaire (LSEQ). Responses to 10 questions will be measured on a slider scale ranging from 0-100. Higher scores indicate better outcomes. Getting to Sleep domain scores were calculated by averaging the responses to Questions 1-3 regarding falling asleep. Quality of Sleep domain scores were calculated by averaging the responses to Questions 4-5 regarding quality of sleep. Awake Following Sleep domain scores were calculated by averaging the responses to Questions 6-7 regarding awakening from sleep. Behaviour Following Wakening domain scores were calculated by averaging the responses to Questions 8-10 regarding feeling, balance, and coordination upon awakening. | Reasons for discrepancy between analyzed and overall number analyzed: withdrawn or lost to follow-up, missed data collection One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis. | Posted | Median | Inter-Quartile Range | score on a scale | preoperatively; morning of postoperative day (POD) 1,2,3,4,7 and at 3 months |
|
|
|
| 12 |
| 1 |
| 12 |
| 4 |
| 12 |
| EG001 | 400mg Cannabidiol | cannabidiol: Epidiolex (cannabidiol) oral solution | 0 | 12 | 0 | 12 | 3 | 12 |
| EG002 | 800mg Cannabidiol | cannabidiol: Epidiolex (cannabidiol) oral solution | 0 | 12 | 1 | 12 | 5 | 12 |
| Oxygen Desaturation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| 1h CBD Levels |
|
|
| 2h CBD Levels |
|
|
| 3h CBD Levels |
|
|
| 4h CBD Levels |
|
|
| 6h CBD Levels |
|
|
| 0h 6-OH-CBD Levels |
|
|
| 1h 6-OH-CBD Levels |
|
|
| 2h 6-OH-CBD Levels |
|
|
| 3h 6-OH-CBD Levels |
|
|
| 4h 6-OH-CBD Levels |
|
|
| 6h 6-OH-CBD Levels |
|
|
| 0h 7-COOH-CBD Levels |
|
|
| 1h 7-COOH-CBD Levels |
|
|
| 2h 7-COOH-CBD Levels |
|
|
| 3h 7-COOH-CBD Levels |
|
|
| 4h 7-COOH-CBD Levels |
|
|
| 6h 7-COOH-CBD Levels |
|
|
| PACU Worst NRS Pain Score |
|
|
| POD1 Worst NRS Pain Score |
|
|
| POD2 Worst NRS Pain Score |
|
|
| POD3 Worst NRS Pain Score |
|
|
| POD4 Worst NRS Pain Score |
|
|
| POD7 Worst NRS Pain Score |
|
|
| 3 Month Worst NRS Pain Score |
|
|
| Preop Least NRS Pain Score |
|
|
| PACU Least NRS Pain Score |
|
|
| POD1 Least NRS Pain Score |
|
|
| POD2 Least NRS Pain Score |
|
|
| POD3 Least NRS Pain Score |
|
|
| POD4 Least NRS Pain Score |
|
|
| POD7 Least NRS Pain Score |
|
|
| 3 Month Least NRS Pain Score |
|
|
| Preop Average NRS Pain Score |
|
|
| PACU Average NRS Pain Score |
|
|
| POD1 Average NRS Pain Score |
|
|
| POD2 Average NRS Pain Score |
|
|
| POD3 Average NRS Pain Score |
|
|
| POD4 Average NRS Pain Score |
|
|
| POD7 Average NRS Pain Score |
|
|
| 3 Month Average NRS Pain Score |
|
|
| POD1 Worst NRS Pain Score - Knee Flexion/Extension |
|
|
| POD2 Worst NRS Pain Score - Knee Flexion/Extension |
|
|
| POD3 Worst NRS Pain Score - Knee Flexion/Extension |
|
|
| POD4 Worst NRS Pain Score - Knee Flexion/Extension |
|
|
| POD7 Worst NRS Pain Score - Knee Flexion/Extension |
|
|
| 3 Month Worst NRS Pain Score - Knee Flexion/Extension |
|
|
| Preop Least NRS Pain Score - Knee Flexion/Extension |
|
|
| POD1 Least NRS Pain Score - Knee Flexion/Extension |
|
|
| POD2 Least NRS Pain Score - Knee Flexion/Extension |
|
|
| POD3 Least NRS Pain Score - Knee Flexion/Extension |
|
|
| POD4 Least NRS Pain Score - Knee Flexion/Extension |
|
|
| POD7 Least NRS Pain Score - Knee Flexion/Extension |
|
|
| 3 Month Least NRS Pain Score - Knee Flexion/Extension |
|
|
| Preop Average NRS Pain Score - Knee Flexion/Extension |
|
|
| POD1 Average NRS Pain Score - Knee Flexion/Extension |
|
|
| POD2 Average NRS Pain Score - Knee Flexion/Extension |
|
|
| POD3 Average NRS Pain Score - Knee Flexion/Extension |
|
|
| POD4 Average NRS Pain Score - Knee Flexion/Extension |
|
|
| POD7 Average NRS Pain Score - Knee Flexion/Extension |
|
|
| 3 Month Average NRS Pain Score - Knee Flexion/Extension |
|
|
| Preop Worst NRS Pain Score - Ambulation |
|
|
| POD1 Worst NRS Pain Score - Ambulation |
|
|
| POD2 Worst NRS Pain Score - Ambulation |
|
|
| POD3 Worst NRS Pain Score - Ambulation |
|
|
| POD4 Worst NRS Pain Score - Ambulation |
|
|
| POD7 Worst NRS Pain Score - Ambulation |
|
|
| 3 Month Worst NRS Pain Score - Ambulation |
|
|
| Preop Least NRS Pain Score - Ambulation |
|
|
| POD1 Least NRS Pain Score - Ambulation |
|
|
| POD2 Least NRS Pain Score - Ambulation |
|
|
| POD3 Least NRS Pain Score - Ambulation |
|
|
| POD4 Least NRS Pain Score - Ambulation |
|
|
| POD7 Least NRS Pain Score - Ambulation |
|
|
| 3 Month Least NRS Pain Score - Ambulation |
|
|
| Preop Average NRS Pain Score - Ambulation |
|
|
| POD1 Average NRS Pain Score - Ambulation |
|
|
| POD2 Average NRS Pain Score - Ambulation |
|
|
| POD3 Average NRS Pain Score - Ambulation |
|
|
| POD4 Average NRS Pain Score - Ambulation |
|
|
| POD7 Average NRS Pain Score - Ambulation |
|
|
| 3 Month Average NRS Pain Score - Ambulation |
|
|
| Preop Worst NRS Pain Score - Stairs |
|
|
| POD1 Worst NRS Pain Score - Stairs |
|
|
| POD2 Worst NRS Pain Score - Stairs |
|
|
| POD3 Worst NRS Pain Score - Stairs |
|
|
| POD4 Worst NRS Pain Score - Stairs |
|
|
| POD7 Worst NRS Pain Score - Stairs |
|
|
| 3 Month Worst NRS Pain Score - Stairs |
|
|
| Preop Least NRS Pain Score - Stairs |
|
|
| POD1 Least NRS Pain Score - Stairs |
|
|
| POD2 Least NRS Pain Score - Stairs |
|
|
| POD3 Least NRS Pain Score - Stairs |
|
|
| POD4 Least NRS Pain Score - Stairs |
|
|
| POD7 Least NRS Pain Score - Stairs |
|
|
| 3 Month Least NRS Pain Score - Stairs |
|
|
| Preop Average NRS Pain Score - Stairs |
|
|
| POD1 Average NRS Pain Score - Stairs |
|
|
| POD2 Average NRS Pain Score - Stairs |
|
|
| POD3 Average NRS Pain Score - Stairs |
|
|
| POD4 Average NRS Pain Score - Stairs |
|
|
| POD7 Average NRS Pain Score - Stairs |
|
|
| 3 Month Average NRS Pain Score - Stairs |
|
|
| POD1 Worst NRS Pain Score - Physical Therapy |
|
|
| POD2 Worst NRS Pain Score - Physical Therapy |
|
|
| POD3 Worst NRS Pain Score - Physical Therapy |
|
|
| POD4 Worst NRS Pain Score - Physical Therapy |
|
|
| POD7 Worst NRS Pain Score - Physical Therapy |
|
|
| 3 Month Worst NRS Pain Score - Physical Therapy |
|
|
| POD1 Least NRS Pain Score - Physical Therapy |
|
|
| POD2 Least NRS Pain Score - Physical Therapy |
|
|
| POD3 Least NRS Pain Score - Physical Therapy |
|
|
| POD4 Least NRS Pain Score - Physical Therapy |
|
|
| POD7 Least NRS Pain Score - Physical Therapy |
|
|
| 3 Month Least NRS Pain Score - Physical Therapy |
|
|
| POD1 Average NRS Pain Score - Physical Therapy |
|
|
| POD2 Average NRS Pain Score - Physical Therapy |
|
|
| POD3 Average NRS Pain Score - Physical Therapy |
|
|
| POD4 Average NRS Pain Score - Physical Therapy |
|
|
| POD7 Average NRS Pain Score - Physical Therapy |
|
|
| 3 Month Average NRS Pain Score - Physical Therapy |
|
|
| POD1 BPI-sf Pain Severity |
|
|
| POD2 BPI-sf Pain Severity |
|
|
| POD3 BPI-sf Pain Severity |
|
|
| POD4 BPI-sf Pain Severity |
|
|
| POD7 BPI-sf Pain Severity |
|
|
| 3 Month BPI-sf Pain Severity |
|
|
| Preop BPI-sf Pain Interference |
|
|
| POD1 BPI-sf Pain Interference |
|
|
| POD2 BPI-sf Pain Interference |
|
|
| POD3 BPI-sf Pain Interference |
|
|
| POD4 BPI-sf Pain Interference |
|
|
| POD7 BPI-sf Pain Interference |
|
|
| 3 Month BPI-sf Pain Interference |
|
|
| Allergic reactions - POD1 |
|
|
| Allergic reactions - POD2 |
|
|
| Allergic reactions - POD3 |
|
|
| Allergic reactions - POD4 |
|
|
| Allergic reactions - POD7 |
|
|
| Allergic reactions - 3 months |
|
|
| Pyrexia (fever) - Postoperatively in the PACU |
|
|
| Pyrexia (fever) - POD1 |
|
|
| Pyrexia (fever) - POD2 |
|
|
| Pyrexia (fever) - POD3 |
|
|
| Pyrexia (fever) - POD4 |
|
|
| Pyrexia (fever) - POD7 |
|
|
| Pyrexia (fever) - 3 months |
|
|
| Somnolence (excessive sleepiness) - POD1 |
|
|
| Somnolence (excessive sleepiness) - POD2 |
|
|
| Somnolence (excessive sleepiness) - POD3 |
|
|
| Somnolence (excessive sleepiness) - POD4 |
|
|
| Somnolence (excessive sleepiness) - POD7 |
|
|
| Somnolence (excessive sleepiness) - 3 months |
|
|
| GI problems (upset stomach, diarrhea) - POD1 |
|
|
| GI problems (upset stomach, diarrhea) - POD2 |
|
|
| GI problems (upset stomach, diarrhea) - POD3 |
|
|
| GI problems (upset stomach, diarrhea) - POD4 |
|
|
| GI problems (upset stomach, diarrhea) - POD7 |
|
|
| GI problems (upset stomach, diarrhea) - 3 months |
|
|
| Dry mouth - POD1 |
|
|
| Dry mouth - POD2 |
|
|
| Dry mouth - POD3 |
|
|
| Dry mouth - POD4 |
|
|
| Dry mouth - POD7 |
|
|
| Dry mouth - 3 months |
|
|
| Escalation of post-operative opioid requirement - IV hydromorphone, subcutaneous hydromorphone |
|
|
| POD2 ORSDS Composite Score |
|
|
| POD3 ORSDS Composite Score |
|
|
| POD4 ORSDS Composite Score |
|
|
| POD7 ORSDS Composite Score |
|
|
| 3 Month ORSDS Composite Score |
|
|
| POD1 ORSDS Nausea Score |
|
|
| POD2 ORSDS Nausea Score |
|
|
| POD3 ORSDS Nausea Score |
|
|
| POD4 ORSDS Nausea Score |
|
|
| POD7 ORSDS Nausea Score |
|
|
| 3 Month ORSDS Nausea Score |
|
|
| POD1 ORSDS Vomiting Score |
|
|
| POD2 ORSDS Vomiting Score |
|
|
| POD3 ORSDS Vomiting Score |
|
|
| POD4 ORSDS Vomiting Score |
|
|
| POD7 ORSDS Vomiting Score |
|
|
| 3 Month ORSDS Vomiting Score |
|
|
| POD1 ORSDS Constipation Score |
|
|
| POD2 ORSDS Constipation Score |
|
|
| POD3 ORSDS Constipation Score |
|
|
| POD4 ORSDS Constipation Score |
|
|
| POD7 ORSDS Constipation Score |
|
|
| 3 Month ORSDS Constipation Score |
|
|
| POD1 ORSDS Difficulty Passing Urine Score |
|
|
| POD2 ORSDS Difficulty Passing Urine Score |
|
|
| POD3 ORSDS Difficulty Passing Urine Score |
|
|
| POD4 ORSDS Difficulty Passing Urine Score |
|
|
| POD7 ORSDS Difficulty Passing Urine Score |
|
|
| 3 Month ORSDS Difficulty Passing Urine Score |
|
|
| POD1 ORSDS Difficulty Concentrating Score |
|
|
| POD2 ORSDS Difficulty Concentrating Score |
|
|
| POD3 ORSDS Difficulty Concentrating Score |
|
|
| POD4 ORSDS Difficulty Concentrating Score |
|
|
| POD7 ORSDS Difficulty Concentrating Score |
|
|
| 3 Month ORSDS Difficulty Concentrating Score |
|
|
| POD1 ORSDS Drowsiness Score |
|
|
| POD2 ORSDS Drowsiness Score |
|
|
| POD3 ORSDS Drowsiness Score |
|
|
| POD4 ORSDS Drowsiness Score |
|
|
| POD7 ORSDS Drowsiness Score |
|
|
| 3 Month ORSDS Drowsiness Score |
|
|
| POD1 ORSDS Dizziness Score |
|
|
| POD2 ORSDS Dizziness Score |
|
|
| POD3 ORSDS Dizziness Score |
|
|
| POD4 ORSDS Dizziness Score |
|
|
| POD7 ORSDS Dizziness Score |
|
|
| 3 Month ORSDS Dizziness Score |
|
|
| POD1 ORSDS Confusion Score |
|
|
| POD2 ORSDS Confusion Score |
|
|
| POD3 ORSDS Confusion Score |
|
|
| POD4 ORSDS Confusion Score |
|
|
| POD7 ORSDS Confusion Score |
|
|
| 3 Month POD1 ORSDS Confusion Score |
|
|
| POD1 ORSDS Fatigue Score |
|
|
| POD2 ORSDS Fatigue Score |
|
|
| POD3 ORSDS Fatigue Score |
|
|
| POD4 ORSDS Fatigue Score |
|
|
| POD7 ORSDS Fatigue Score |
|
|
| 3 Month ORSDS Fatigue Score |
|
|
| POD1 ORSDS Itchiness Score |
|
|
| POD2 ORSDS Itchiness Score |
|
|
| POD3 ORSDS Itchiness Score |
|
|
| POD4 ORSDS Itchiness Score |
|
|
| POD7 ORSDS Itchiness Score |
|
|
| 3 Month ORSDS Itchiness Score |
|
|
| POD1 ORSDS Dry Mouth Score |
|
|
| POD2 ORSDS Dry Mouth Score |
|
|
| POD3 ORSDS Dry Mouth Score |
|
|
| POD4 ORSDS Dry Mouth Score |
|
|
| POD7 ORSDS Dry Mouth Score |
|
|
| 3 Month ORSDS Dry Mouth Score |
|
|
| POD1 ORSDS Headache Score |
|
|
| POD2 ORSDS Headache Score |
|
|
| POD3 ORSDS Headache Score |
|
|
| POD4 ORSDS Headache Score |
|
|
| POD7 ORSDS Headache Score |
|
|
| 3 Month ORSDS Headache Score |
|
|
| POD1 HADS Anxiety Score |
|
|
| POD2 HADS Anxiety Score |
|
|
| POD3 HADS Anxiety Score |
|
|
| POD4 HADS Anxiety Score |
|
|
| POD7 HADS Anxiety Score |
|
|
| 3 Month HADS Anxiety Score |
|
|
| Preop HADS Depression Score |
|
|
| POD1 HADS Depression Score |
|
|
| POD2 HADS Depression Score |
|
|
| POD3 HADS Depression Score |
|
|
| POD4 HADS Depression Score |
|
|
| POD7 HADS Depression Score |
|
|
| 3 Month HADS Depression Score |
|
|
|
| Meloxicam consumption |
|
|
| Tizanidine |
|
| Gabapentin or pregabalin |
|
| Gabapentin |
|
| Pregabalin |
|
| Lidocaine patches |
|
| Intravenous hydromorphone (non-PCA) |
|
| Subcutaneous hydromorphone |
|
| IVPCA hydromorphone |
|
| Either IV hydromorphone (non-PCA), Subcutaneous hydromorphone, or IVPCA hydromorphone |
|
| Acetaminophen consumption |
|
|
| Ketorolac consumption |
|
|
| Meloxicam consumption |
|
|
| POD0-POD7 Methocarbamol |
|
|
| POD0-POD7 Tizanidine |
|
|
| POD0-POD7 Gabapentin or pregabalin |
|
|
| POD0-POD7 Gabapentin |
|
|
| POD0-POD7 Pregabalin |
|
|
| POD0-POD7 Lidocaine patches |
|
|
| POD0-POD7 Intravenous hydromorphone (non-PCA) |
|
|
| POD0-POD7 Subcutaneous hydromorphone |
|
|
| POD0-POD7 IVPCA hydromorphone |
|
|
| POD0-POD7 Either IV hydromorphone (non-PCA), Subcutaneous hydromorphone, or IVPCA hydromorphone |
|
|
| 3 Month Opioid use |
|
|
| 3 Month Acetaminophen use |
|
|
| 3 Month Meloxicam use |
|
|
| 3 Month Methocarbamol or tizanidine use |
|
|
| 3 Month Methocarbamol use |
|
|
| 3 Month Tizanidine use |
|
|
| 3 Month Gabapentin or pregabalin use |
|
|
| 3 Month Gabapentin use |
|
|
| 3 Month Pregabalin use |
|
|
| 3 Month Lidocaine patches use |
|
|
| Bang Blinding Index - Outcomes Assessor |
|
| Ambulation 100 feet |
|
|
| 4-Step Stairs |
|
|
| Preoperative Range of Motion - Right Knee Extension |
|
|
| Preoperative Range of Motion - Left Knee Flexion |
|
|
| Preoperative Range of Motion - Left Knee Extension |
|
|
| Postoperative Range of Motion - Right Knee Flexion |
|
|
| Postoperative Range of Motion - Right Knee Extension |
|
|
| Postoperative Range of Motion - Left Knee Flexion |
|
|
| Postoperative Range of Motion - Left Knee Extension |
|
|
| POD1-2 Actigraphy Sleep Efficiency |
|
|
| POD2-3 Actigraphy Sleep Efficiency |
|
|
| POD1-2 Actigraphy Sleep Time |
|
| POD2-3 Actigraphy Sleep Time |
|
| POD1 LSEQ Getting To Sleep Domain Score |
|
|
| POD2 LSEQ Getting To Sleep Domain Score |
|
|
| POD3 LSEQ Getting To Sleep Domain Score |
|
|
| POD4 LSEQ Getting To Sleep Domain Score |
|
|
| POD7 LSEQ Getting To Sleep Domain Score |
|
|
| 3 Month LSEQ Getting To Sleep Domain Score |
|
|
| Preop LSEQ Quality Of Sleep Domain Score |
|
|
| POD1 LSEQ Quality Of Sleep Domain Score |
|
|
| POD2 LSEQ Quality Of Sleep Domain Score |
|
|
| POD3 LSEQ Quality Of Sleep Domain Score |
|
|
| POD4 LSEQ Quality Of Sleep Domain Score |
|
|
| POD7 LSEQ Quality Of Sleep Domain Score |
|
|
| 3 Month LSEQ Quality Of Sleep Domain Score |
|
|
| Preop LSEQ Awake Following Sleep Domain Score |
|
|
| POD1 LSEQ Awake Following Sleep Domain Score |
|
|
| POD2 LSEQ Awake Following Sleep Domain Score |
|
|
| POD3 LSEQ Awake Following Sleep Domain Score |
|
|
| POD4 LSEQ Awake Following Sleep Domain Score |
|
|
| POD7 LSEQ Awake Following Sleep Domain Score |
|
|
| 3 Month LSEQ Awake Following Sleep Domain Score |
|
|
| Preop LSEQ Behaviour Following Wakening Domain Score |
|
|
| POD1 LSEQ Behaviour Following Wakening Domain Score |
|
|
| POD2 LSEQ Behaviour Following Wakening Domain Score |
|
|
| POD3 LSEQ Behaviour Following Wakening Domain Score |
|
|
| POD4 LSEQ Behaviour Following Wakening Domain Score |
|
|
| POD7 LSEQ Behaviour Following Wakening Domain Score |
|
|
| 3 Month LSEQ Behaviour Following Wakening Domain Score |
|
|