両側人工膝関節全置換術のためのカンナビジオール

プラセボコンパレーター：オラ甘いSF

他の：オラ甘いSF

オラスイートSFプラセボ

実験的：カンナビジオール 400mg

薬：カンナビジオール

エピディオレックス（カンナビジオール）経口液剤

他の名前：

• エピディオレックス

実験的：カンナビジオール800mg

薬：カンナビジオール

エピディオレックス（カンナビジオール）経口液剤

他の名前：

• エピディオレックス

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

CBDの薬物動態

血液中のCBDのレベル。 これは、採血とラボ分析を使用して測定されます。

簡単な痛みのインベントリの短い形式

簡単な痛みのインベントリの短い形式は、痛みの重症度と機能への影響を測定します。 0 から 10 までの痛みを測定します。0 はまったく痛みがなく、10 は想像できる最悪の痛みです。 機能への影響を 0 ～ 10 で測定します。0 はまったく影響がなく、10 は完全に影響があります。

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.

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.

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.

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

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.

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

Cumulative Inpatient Analgesic Use (Non-opioid)

Total non-opioid medication usage

Number of Participants With Opioid and Non-opioid Medication Use

Opioid and non-opioid medication use by count (%)

Opioid & Non-opioid Analgesic Consumption

Total opioid (morphine milligram equivalents) & non-opioid medication usage

Number of Participants With Opioid and Non-opioid Medication Use

Opioid & non-opioid medication use by count (%)

Hospital Length of Stay

Length of stay measured in hours from end of surgery to 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.

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

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

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.

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.

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.