Effect of Dexmedetomidine and Bupivacaine for Paravertebral Block
Evaluation Effect of Adding Dexmedetomidine to Bupivacaine for Paravertebral Block in Femoral Fractures
調査の概要
状態
詳細な説明
Fracture femur is a common injury which is associated with excruciating pain . This pain is one of the most important causes of postoperative morbidity and mortality when it is insufficiently treated pain. Pain induces neuroendocrine stress response causing problems like as reduction in vital capacity, pneumonia, tachycardia, hypertension, myocardial ischemia and even infarction. These problems can be prevented by successful management of postoperative pain.
In patients with proximal femoral fracture, the use of paravertebral blockade produces reliable level of analgesia without need for additional nursing skills or monitoring in the postoperative period. Paravertebral blockade by injection local anesthetic solution alongside the vertebral column produces ipsilateral analgesia.
Currently available local anesthetics as bupivacaine may not provide reliable periods of analgesia resulting in block resolution before the period of worst postoperative pain. The use of a large volume of local anesthetic is one of methods to overcome this problem that may lengthen the duration of analgesia but at increased risk of local anesthetic toxicity. Adding adjuvants is another potential alternative.
Dexmedetomidine, a selective α 2 agonist, has been used to prolong the duration of analgesia of nerve blocks. Dexmedetomidine has also been reported to enhance central and peripheral nerve blockade. Alpha adrenoceptors located at the nerve endings have a possible role in the analgesic mechanisms by preventing norepinephrine release. The spinal mechanism is the principle mechanism for the analgesic action of dexmedetomidine.
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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Mansoura、DK、エジプト、050
- Mansoura University
-
-
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.
- Severe or uncompensated cardiovascular disease.
- Severe or uncompensated renal disease.
- Severe or uncompensated hepatic disease.
- Severe or uncompensated endocrinal disease.
- Pregnancy.
- Postpartum ladies.
- Lactating females.
- Allergy to any of the study medications .
- Coagulation disorders.
- Infection at the site of needle insertion
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：防止
- 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 |
|---|---|
|
プラセボコンパレーター：Bupivacaine group
Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5% and water soluble radio-opaque dye.
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Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5% and water soluble radio-opaque dye.
|
|
アクティブコンパレータ：Mixture of bupivacaine and dexmedetomidine group
Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5%, water soluble radio-opaque dye and 1 ug/kg of dexmedetomidine
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Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5%, water soluble radio-opaque dye, and1 ug/kg of dexmedetomidine
|
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 |
|---|---|---|
|
Scale for radiological spread of the injectate
時間枠：for 20 min after performing the blockade
|
It will be assessed using the following scale -2; spread for two vertebral levels below the site of injection, -1; spread for one vertebral level below the site of injection, 0; stays at the level of injection, +2; spread for two vertebral levels above the site of injection, +1; spread for one vertebral level above the site of injection
|
for 20 min after performing the blockade
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain scores
時間枠：For 48 hours after surgery
|
The severity of pain will be assessed using a visual analog scale (VAS)
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For 48 hours after surgery
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Duration of postoperative analgesia
時間枠：for 24 hours after surgery
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The period from completion of the block to time of administration of the first request of rescue analgesic for postoperative pain will be recorded
|
for 24 hours after surgery
|
|
Postoperative analgesic consumption
時間枠：for 48 hours after surgery
|
Total postoperative analgesic consumption
|
for 48 hours after surgery
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Reem A El sharkawy, MD、Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
- スタディディレクター：Mohamed Y Makharita, MD、Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
- スタディチェア：Nabil Abd-El Raouf, MD、Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
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 (見積もり)
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
追加の関連 MeSH 用語
その他の研究ID番号
- MD ∕ 128
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?
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