Dexmedetomidine Addition to Fascia Iliaca Compartment Block
Effects of Dexmedetomidine Addition to Bupivacaine on the Quality of Fascia Iliaca Compartment Block (FICB) in Children Undergoing Femur Fracture Surgery
Fractures of the shaft of femur (FSF) are common in children, especially isolated fractures of the mid-third of the femur which are intensely painful. The pain of the fracture is thought to originate from the femoral shaft periosteum and muscle spasm from the quadriceps mechanism. Fascia iliaca compartment block FIC is easy and simple technique, there is no need for high-skill or expensive equipments. It has higher success rate in more than 90%of the children thigh procedures.
Potentially dexmedetomidine has become an alternative to clonidine, it is a highly selective α2 agonist having about an 8-10 times affinity for α2 adrenergic receptors than clonidine and much less α1 effects, which is responsible for the hypnotic and analgesic effects. Perinural dexmedetomidine in combination with bupivacaine or ropivacaine enhance sensory and motor block without neurotoxicity in experimental studies.It has been reported to improve the quality of intrathecal, Epidural, and caudal anesthesia in children. Also, it is safe and effective in IV regional anesthetic and axillary block in adult. No study-up to the date -has been carried to evaluate its effect on the character of fascia iliaca compartment blocks as adjuvant to bupivacaine. The objectives of this study were designed to detect the effects of addition dexmedetomidine (Precedex- Abbot) as adjuvant to bupivacaine for fascia iliaca block on the quality of postoperative analgesia and also to determine its effects on the hemodynamics, recovery behaviors, sedation and possible side effects in children undergoing thigh surgeries (fracture femur).
調査の概要
状態
詳細な説明
All the patients were premedicated with oral midazolam 0.5 mg/kg,1 hour prior to induction. General anesthesia was induced by inhaled sevoflurane.
Laryngeal mask airway with appropriate-size for body weight was slipped, then an intravenous line was inserted,anesthesia was maintained with sevoflurane (Minimum Alveolar Concentration (MAC)from 1-1.5 in air/oxygen to maintain the Heart rate (HR) and mean arterial blood pressure (MAP) within 20% of their baseline values.
A rescue dose of fentanyl 0.5 µg/kg was given if the MAC of sevoflurane exceeded 1.7 whereas HR and MAP exceeded 20% of their baseline values.
Fascia iliaca compartment block was performed as described by Dalens et al technique.
An axillary nerve block needle was inserted with an angle of 45±60º with the skin at (0.5±1cm) below the inguinal crease at the junction of the medial two-thirds and the lateral one-third of the line between the pubic tubercle and anterior superior iliac spine.
The needle was advanced until the perception of two losses of resistance (pop) was noted which corresponded to the crossing of fascia lata and then fascia iliaca.
Hypotension was defined as systolic arterial pressure 70 plus twice the age in years and associated with altered peripheral perfusion.
Bradycardia was defined as HR below 80 beats/min. Delayed anesthetic emergence was defined as 20 min elapsing from the end of surgery to exiting the operating theater.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
DK
-
Mansoura、DK、エジプト、050
- Mansoura University Hospitals
-
-
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:
- Children 2-6 years
- American Society of Anesthesiologist physical class I and II
- Fracture femur surgery
Exclusion Criteria:
- known allergy to the study drugs
- suspected coagulopathy
- infection at the site of the block
- neurological diseases
- history of developmental delay
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：4倍
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：Group B
received 1 ml/kg bupivacaine 0.25%.
|
Fascia iliaca compartment block was performed as described by Dalens et al technique.
|
|
アクティブコンパレータ：group BD
received 1 ml/kg bupivacaine 0.25% with dexmedetomidine 2 μg/kg
|
Fascia iliaca compartment block was performed as described by Dalens et al technique.
|
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 pain scores
時間枠：every 4 hours after surgery
|
Postoperative using the Objective Pain Scale (children <6 yr) which described by Hannallah et al.
|
every 4 hours after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Vital signs
時間枠：before surgery, and every 20 min during surgery, and each 6 hours after surgery
|
Heart rate, mean arterial pressure and oxygen saturation
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before surgery, and every 20 min during surgery, and each 6 hours after surgery
|
|
Intraoperative hypotension
時間枠：for 24 hours after surgery
|
for 24 hours after surgery
|
|
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Intraoperative bradycardia
時間枠：for 24 hours after surgery
|
for 24 hours after surgery
|
|
|
Postoperative sedation
時間枠：every 4 hours after surgery
|
Sedation score was assessed using Ramsay's sedation
|
every 4 hours after surgery
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Ghada F E l-Rahmawy, MD、Anesthesia and Surgical ICU, College of Medicine, Mansoura University, Mansoura City, Egypt
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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
- R 54
- R-54 (その他の識別子：Anestheia Dept., Mansoura University)
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