鏡視下手術後のドロナビノール
鏡視下手術後の術後疼痛の治療のためのドロナビノール：無作為パイロット試験
The purpose of the proposed study is to evaluate the efficacy of dronabinol for postoperative pain after arthroscopic surgery of the knee. The investigators hypothesize that dronabinol will relieve pain, reduce opioid consumption and will result in few negative side effects. If this pilot study shows promising results the investigators will expand the trial to include additional arthroscopic surgeries (hip, shoulder) and other types of orthopaedic surgery.
調査の概要
状態
介入・治療
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究場所
-
-
Illinois
-
Chicago、Illinois、アメリカ、60611
- Northwestern University Feinberg School of Medicine
-
-
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:
-
Age 18 years or older
-
Patient who will undergo arthroscopic surgery of the knee including, but not limited to,
- Meniscectomy
- Synovectomy
- Chondroplasty
- Loose body removal
Exclusion Criteria:
-
Patients under age 18 years
-
Patients who cannot provide consent
-
Patients who are pregnant, breast feeding, or are trying to become pregnant during the study period
-
Patients with an allergy to any of the study drugs
-
Patient who are lactose-intolerant
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Revision surgery
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Open surgery
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Comorbidities preventing surgery
-
Patients with a history of mania, depression, or schizophrenia
-
Patients taking any of the following drugs or supplements
- Anticholinergic agents
- Benzodiazepines
- Central nervous system depressants
- Droperidol
- Hydroxyzine
- Levomepromazine or methotrimeprazine
- Monoamine oxidase inhibitors
- Ritonavir
- Selective serotonin reuptake inhibitors
- Sympathomimetics
- St. John's Wort
-
Current diagnosed alcohol or drug abuse
-
Patients who cannot or will not abide by the medication restrictions listed below
Medication restrictions
- Participants must agree to abstain from using recreational or medical marijuana products or cannabidiol (CBD) in any form during the treatment period
- Participants should not drink alcohol or take other drugs while taking the study drug or hydrocodone/acetaminophen
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Dronabinol
Patients will received dronabinol (5mg) twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery |
5mg 2x daily for 7 days
他の名前：
|
|
プラセボコンパレーター：Placebo
Patients will received placebo twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery |
1 caplet 2x daily for 7 days |
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 |
|---|---|---|
|
Opioid consumption
時間枠：up to 7 days post-surgery
|
Count of number of hydrocodone/acetaminophen tablet consumed |
up to 7 days post-surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain Visual Analog Scale (VAS)
時間枠：up to 7 days post-surgery
|
Scored from 0 (no pain) to 10 (worst possible pain) |
up to 7 days post-surgery
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.1 - Pain Interference
時間枠：up to 21 days post-surgery
|
PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population (usually U.S. general population). A low score indicates less pain interference (better outcome) and a high score indicates more pain interference (worse outcome). |
up to 21 days post-surgery
|
|
PROMIS Bank v2.0 - Pain Behavior
時間枠：up to 21 days post-surgery
|
PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50. A low score indicates less pain (better outcome) and a high score indicates more pain (worse outcome). |
up to 21 days post-surgery
|
|
PROMIS Bank v2.0 - Physical Function
時間枠：up to 21 days post-surgery
|
PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50. A low score indicates worse physical functioning and a high score indicates better physical functioning. |
up to 21 days post-surgery
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Vehniah K Tjong, MD、Northwestern Feinberg School of Medicine
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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。