The Influence of Warm Bupivacaine on Supraclavicular Plexus Block Characteristics
The Influence of Bupivacaine Temperature on Supraclavicular Plexus Block Characteristics
Despite PH adjustment of local anesthetic solution improves the quality of the block in all respects with special advantage of early onset of sensory and motor block, adequate level of analgesia, and prolongation of duration of block, the effect of warmed bupivacaine should have the same effect which have not been evaluated on supraclavicular plexus block for upper limb surgery.
The warmed bupivacaine used in supraclavicular plexus block may reduce sensory and motor block onset and prolong the duration of analgesia when compared to bupivacaine at operating room temperature.
調査の概要
状態
詳細な説明
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
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DK
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Mansourah、DK、エジプト、050
- mansoura university, faculty of medicine
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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:
- American Society of Anesthesiologists physical class I or II
Exclusion Criteria:
- Patient refusal.
- Pregnancy
- Neuromuscular diseases (as myopathies, myasthenia gravies…)
- Hematological diseases
- Bleeding disorders
- Coagulation abnormality.
- Psychiatric diseases.
- Local skin infection
- Sepsis at site of the block.
- Known intolerance to the study drugs.
- Body Mass Index > 40 Kg/m2.
- Bilateral upper limb injury to be performed at the same procedure.
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:支持療法
- 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 |
---|---|
実験的:Warm bupivacaine at (37°c)
Warmed bupivacaine at body temperature will be administered
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Bupivacaine 0.5%, 30 mL, warmed to 37◦C for 20 minutes.
The empty syringes and needles, in their packaging, will be held at the same temperature before initiating the block.
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アクティブコンパレータ:Bupivacaine at operating room temperature (23°c)
Bupivacaine at temperature of 23°C will be administered
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Bupivacaine 0.5%, 30 ml held in crash shelf of the operating room temperature at 23◦C.
The empty syringes and needles will be held in the same temperature before use.
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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 |
---|---|---|
Time to onset of sensory block
時間枠:for 30 min following injection
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defined as the time interval between the end of local anesthetic injection and the loss of sensation to pinprick (sensory score = 1)
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for 30 min following injection
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Time to onset of motor block
時間枠:For 3 hours after the injection of local anesthetic
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defined as time interval between the end of local anesthetic injection and (motor score = 1) in the distributions of all 4 peripheral nerves.
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For 3 hours after the injection of local anesthetic
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Heart rate
時間枠:For 3 hours after the injection of local anesthetic
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For 3 hours after the injection of local anesthetic
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Blood pressure
時間枠:For 3 hours after the injection of local anesthetic
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For 3 hours after the injection of local anesthetic
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oxygen saturation in the peripheral blood
時間枠:For 3 hours after the injection of local anesthetic
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For 3 hours after the injection of local anesthetic
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Duration of sensory block
時間枠:For 24 hours after the injection of local anesthetic
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defined as the interval between end of injection and complete end of sensory block (score=2)
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For 24 hours after the injection of local anesthetic
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Duration of motor block
時間枠:For 24 hours after the injection of local anesthetic
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defined as the interval between end of injection and complete recovery of normal motor function (score=0), respectively.
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For 24 hours after the injection of local anesthetic
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The severity of postoperative pain
時間枠:For 24 hours after the injection of local anesthetic
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will be measured and recorded by using a 100-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 100 indicates the worst possible pain.
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For 24 hours after the injection of local anesthetic
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Time for first analgesic request
時間枠:For 24 hours after the injection of local anesthetic
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Time to the first receiving of rescue analgesic from the time of blockade
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For 24 hours after the injection of local anesthetic
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Total analgesics received
時間枠:for 24 hrs after the injection of local anesthetic
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Cumulative use of rescue analgesics after performing the blockade
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for 24 hrs after the injection of local anesthetic
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Satisfaction Score
時間枠:for 48 hrs after the injection of local anesthetic
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Using score including 5-Excellent, 4-Very Good, 3-Good, 2-Fair, and 1-Poor
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for 48 hrs after the injection of local anesthetic
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協力者と研究者
スポンサー
捜査官
- スタディチェア:Mohamed Y Makharita, MD、Professor of Anesthesia and Surgical Intensive Care
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
本研究に関する用語
その他の研究ID番号
- MFM-IRB, MS/17.05.143
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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Warm bupivacaine at (37°c)の臨床試験
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