A Study to Evaluate the Outcomes of Cannabinoid (CBD) Roll-on Topical Stick in Primary Total Knee Arthroplasty
Prospective Blinded Randomized Controlled Trial Evaluating the Outcomes of Cannabinoid (CBD) Roll-on Topical Stick in Primary Total Knee Arthroplasty
Total knee arthroplasty (TKA) is one the most common surgical treatments performed for end stage degenerative arthritis of the knee. More than 700,000 procedures are currently performed yearly in the United States. This procedure usually results in moderate-to-severe pain in the immediate post-operative period. Optimal pain control may allow early mobilization, accelerate rehabilitation, improve patient satisfaction, decrease length-of-stay, and optimize functional outcomes. The challenge, however, is to manage pain with alternative methods, reducing the role of opiate medications, which are highly addictive with myriad side effects.
In this prospective randomized double-blinded controlled study, the investigators aim to evaluate the benefits of an over-the-counter (OTC) transdermal CBD preparation in patients undergoing primary total knee arthroplasty as a novel adjunct to the standard multi-modal analgesic regimen, to reduce postoperative pain and reduce the need for opiates after total knee arthroplasty.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19107
- Rothman Orthopaedic Institute
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients who have general anesthesia
- Patients who have documented allergic reactions to ropivacaine in the local infiltration agents
- Patients who have a contra-indication to the use of non-steroidal anti-inflammatory medications or are using therapeutic anticoagulation precluding them from using non-steroidal anti-inflammatory medications
- Patients unable to complete a 100-ft walk baseline
- Patients undergoing total knee arthroplasty as a conversion procedure following previous surgery
- Patients undergoing TKA for posttraumatic arthritis
- Patients undergoing TKA for steroid-induced or spontaneous avascular necrosis
- Workers compensation patients
- Patients refusing or not candidates for peripheral nerve blocks
- Patients undergoing unicompartmental knee arthroplasty
- Patients undergoing patellofemoral arthroplasty
- Patients undergoing bilateral simultaneous or sequential primary total knee arthroplasty within the same hospital stay
- Patients who have previously reported allergy to tetrahydrocannabinol or other cannabinoid compounds or develop allergic reactions to the formulation following use
- Patients who are pregnant or choosing to be pregnant during the 6-week study period or are breast feeding during the study period
- Patients who are on chronic narcotics pre-operatively
- Patients who have end-stage cirrhosis, end-stage renal failures, or psychiatric conditions preventing adequate assessment of study outcome metrics
- Patients with adequate cognitive function to participate and complete questionnaires for the study.
- Patients unable or unwilling to follow-up and complete questionnaires for the study
- Patients with active cancer and undergoing treatment precluding the assessment of outcome metrics
- Patients with a history or diagnosis of chronic pain syndrome or Complex regional pain syndrome (CRPS)
- Patients who are determined to be in severe pain from other concomitant conditions
Exclusion Criteria:
- patients <18 and >80
- any patient who does not meet the inclusion criteria listed for this study
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Group 1: (CBD + MO cohort)
Roll on stick containing CBD and mineral oils (CBD + MO cohort)
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CBD oil Roll-On Stick
Mineral Oil- Roll on Stick
|
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アクティブコンパレータ：Group 2: (MO cohort)
Roll on stick containing mineral oils only (MO cohort)
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Mineral Oil- Roll on Stick
|
|
アクティブコンパレータ：Group 3: (CBD Cohort)
Roll on stick containing CBD only (CBD cohort)
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CBD oil Roll-On Stick
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プラセボコンパレーター：Group 4: (Roll-on stick only with NO CBD or MO-placebo cohort)
Roll on stick with neither CBD nor essential oils (Roll-on stick only with NO CBD or MO-placebo cohort)
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Roll- On stick with no CBD and no Mineral Oil
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative change in pain and change the need for opiates after total knee arthroplasty.
時間枠：14 days
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opioid consumption after surgery will be calculated in morphine equivalents
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14 days
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。