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Dexmedetomidine Addition to Fascia Iliaca Compartment Block

15 mars 2015 uppdaterad av: Mohamed R El Tahan, Mansoura University

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).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

28

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Egypten
    • DK
      • Mansoura, DK, Egypten, 050
        • Mansoura University Hospitals

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

2 år till 6 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: Group B
received 1 ml/kg bupivacaine 0.25%.
Procedur: Fascia iliaca compartment block
Fascia iliaca compartment block was performed as described by Dalens et al technique.
Aktiv komparator: group BD
received 1 ml/kg bupivacaine 0.25% with dexmedetomidine 2 μg/kg
Procedur: Fascia iliaca block
Fascia iliaca compartment block was performed as described by Dalens et al technique.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Postoperative pain scores
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Vital signs
Tidsram: before surgery, and every 20 min during surgery, and each 6 hours after surgery
Heart rate, mean arterial pressure and oxygen saturation
before surgery, and every 20 min during surgery, and each 6 hours after surgery
Intraoperative hypotension
Tidsram: for 24 hours after surgery
for 24 hours after surgery
Intraoperative bradycardia
Tidsram: for 24 hours after surgery
for 24 hours after surgery
Postoperative sedation
Tidsram: every 4 hours after surgery
Sedation score was assessed using Ramsay's sedation
every 4 hours after surgery

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Mansoura University

Utredare

  • Huvudutredare: Ghada F E l-Rahmawy, MD, Anesthesia and Surgical ICU, College of Medicine, Mansoura University, Mansoura City, Egypt

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2012

Primärt slutförande (Faktisk)

1 mars 2012

Avslutad studie (Faktisk)

1 maj 2012

Studieregistreringsdatum

Först inskickad

14 maj 2012

Först inskickad som uppfyllde QC-kriterierna

15 maj 2012

Första postat (Uppskatta)

16 maj 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

17 mars 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 mars 2015

Senast verifierad

1 mars 2015

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • R 54
  • R-54 (Annan identifierare: Anestheia Dept., Mansoura University)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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