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).
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 1
Kontakty a umístění
Studijní místa
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DK
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Mansoura, DK, Egypt, 050
- Mansoura University Hospitals
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Komparátor placeba: Group B
received 1 ml/kg bupivacaine 0.25%.
|
Fascia iliaca compartment block was performed as described by Dalens et al technique.
|
|
Aktivní komparátor: group BD
received 1 ml/kg bupivacaine 0.25% with dexmedetomidine 2 μg/kg
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Fascia iliaca compartment block was performed as described by Dalens et al technique.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Postoperative pain scores
Časové okno: every 4 hours after surgery
|
Postoperative using the Objective Pain Scale (children <6 yr) which described by Hannallah et al.
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every 4 hours after surgery
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Vital signs
Časové okno: 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
|
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Intraoperative hypotension
Časové okno: for 24 hours after surgery
|
for 24 hours after surgery
|
|
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Intraoperative bradycardia
Časové okno: for 24 hours after surgery
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for 24 hours after surgery
|
|
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Postoperative sedation
Časové okno: every 4 hours after surgery
|
Sedation score was assessed using Ramsay's sedation
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every 4 hours after surgery
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Ghada F E l-Rahmawy, MD, Anesthesia and Surgical ICU, College of Medicine, Mansoura University, Mansoura City, Egypt
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- R 54
- R-54 (Jiný identifikátor: Anestheia Dept., Mansoura University)
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Klinické studie na Fascia iliaca compartment block
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Peking Union Medical College HospitalZatím nenabíráme
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Zuyderland Medisch CentrumFresenius KabiUkončenoBolest | Zlomenina stehenní kosti | Analgezie | Anestezie, lokální | Urgentní medicína | Ovládnutí bolesti | Ultrasonografie | Morfium | Fascia | Anestetika, lokální | Analgezie, kontrolovaná pacientem | LidéHolandsko