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- Sperimentazione clinica NCT02696915
Fascia Iliaca Compartment Block for Proximal-end Femur Fractures
Fascia Iliaca Compartment Block in Proximal End Femur Fractures, Does it Make a Difference?
Fracture femur is a common injury which is associated with excruciating pain. Positioning for neuraxial blocks is always challenging because even slight overriding of the fracture ends is intensely painful .It can causing major patient distress which accompanied by well-known physiological sequelae such as sympathetic activation causing tachycardia, hypotension, and increased cardiac work that may compromise high-risk cardiac patients.
Fascia iliaca compartment block is highly effective in blocking lateral cutaneous nerve of the thigh and femoral nerve. Fascia iliaca compartment block is not only easy to perform but it is also associated with minimal risk as the local anesthetic is injected at a safe distance from the femoral artery and femoral nerve. It is always safe to perform the fascia iliaca compartment block prior to spinal anesthesia as the patient can respond during administration of the local anesthetic and can prevent intra-neuronal injections
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
On arrival to the pre-operative holding area half hour before the scheduled surgery. Patient will be connected to basal monitoring devices; pulse oximetry and non- invasive blood pressure. Fascia iliaca compartment block will be performed with the aid of ultrasound device in all cases.The injected local anesthetic solution will be prepared by a staff member who was not involved in the study) according to the randomization. After 20 minutes from the injection the investigators will assessed nerves that had been blocked.
On arrival to the operative theater, under complete aseptic technique spinal anesthesia will be carried out in the sitting position (if there is severe pain at positioning we will use lateral position) at space between L3-4 or L4-5 using a 25-gauge spinal quincke needle. After feeling the desired space, the needle will be advanced (paramedian approach) till free flow of cerebrospinal fluid dropped from the needle then 15 mg hyperbaric bupivacaine+20mic fentanyl will be injected.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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DK
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Mansoura, DK, Egitto, 050
- Mansoura University Hospitals
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- American Society of Anesthesiologist physical status I to III
- Patients scheduled for fixation for proximal end femur fracture
Exclusion Criteria:
- Patients refusal
- Morbid obese patients (BMI>40)
- Bleeding diathesis
- Previous femoral bypass surgery
- Inguinal hernia
- Inflammation/infection over injection site
- Peripheral neuropathy
- Allergy to local anesthetics agents used.
- Severely altered consciousness level
- Psychiatric disorders
- Polytrauma
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore placebo: Placebo
Patients received ultrasound guided fascia iliaca compartment block using 40 ml of saline 0.9%.
Then intrathecal medications will be administered.
|
Patients received ultrasound guided fascial iliaca compartment blockade using normal saline 0.9%, 40 ml
Ultrasound guided fascia iliaca compartment block
Intrathecal hyperbaric bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms
|
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Comparatore attivo: Bupivacaine
Patients received ultrasound guided fascia iliaca compartment block using 40 ml of 0.25% bupivacaine.
Then intrathecal medications will be administered.
|
Ultrasound guided fascia iliaca compartment block
Intrathecal hyperbaric bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms
Patients received ultrasound guided fascial iliaca compartment blockade using bupivacaine 0.25%, 40 ml
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pain scores
Lasso di tempo: For 24 hours after performance the blockade
|
Pain was assessed using visual analogue score
|
For 24 hours after performance the blockade
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Heart rate
Lasso di tempo: For 24 hours after performance the blockade
|
For 24 hours after performance the blockade
|
|
|
Blood pressure
Lasso di tempo: For 24 hours after performance the blockade
|
For 24 hours after performance the blockade
|
|
|
Peripheral oxygen saturation
Lasso di tempo: For 24 hours after performance the blockade
|
For 24 hours after performance the blockade
|
|
|
Time to performing spinal anesthesia
Lasso di tempo: For 30 min after placement of patient in the optimum position
|
Time from the placement of patient in the optimum position to the intra-thecal injection of bupivacaine
|
For 30 min after placement of patient in the optimum position
|
|
Number of trials of dural puncture
Lasso di tempo: For 30 min after placement of patient in the optimum position
|
For 30 min after placement of patient in the optimum position
|
|
|
Duration of motor blockade
Lasso di tempo: For 12 hours after performing spinal anesthesia
|
For 12 hours after performing spinal anesthesia
|
|
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Duration of sensory blockade
Lasso di tempo: For 12 hours after performing spinal anesthesia
|
For 12 hours after performing spinal anesthesia
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Duration of analgesia
Lasso di tempo: For 24 hours after performing spinal anesthesia
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Time from performing spinal anesthesia to first analgesic request
|
For 24 hours after performing spinal anesthesia
|
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Cumulative consumption of analgesics
Lasso di tempo: For 24 hours after performing spinal anesthesia
|
Total opioid or other analgesics received for the first 24 hours after surgery.
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For 24 hours after performing spinal anesthesia
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Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Reem A El Sharkawy, MD, Lecturer of Anesthesia and Surgical Intensive care
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Ferite e lesioni
- Lesioni alla gamba
- Fratture femorali
- Fratture, ossa
- Effetti fisiologici delle droghe
- Depressori del sistema nervoso centrale
- Agenti del sistema nervoso periferico
- Analgesici
- Agenti del sistema sensoriale
- Anestetici, per via endovenosa
- Anestetici, Generale
- Anestetici
- Analgesici, oppioidi
- Narcotici
- Adiuvanti, Anestesia
- Anestetici, Locali
- Fentanil
- Bupivacaina
Altri numeri di identificazione dello studio
- MS/811
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .