- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
DK
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Mansoura, DK, Egypten, 050
- Mansoura University Hospitals
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Placebo-jämförare: 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
|
Aktiv komparator: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Pain scores
Tidsram: For 24 hours after performance the blockade
|
Pain was assessed using visual analogue score
|
For 24 hours after performance the blockade
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Heart rate
Tidsram: For 24 hours after performance the blockade
|
For 24 hours after performance the blockade
|
|
Blood pressure
Tidsram: For 24 hours after performance the blockade
|
For 24 hours after performance the blockade
|
|
Peripheral oxygen saturation
Tidsram: For 24 hours after performance the blockade
|
For 24 hours after performance the blockade
|
|
Time to performing spinal anesthesia
Tidsram: 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
Tidsram: 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
Tidsram: For 12 hours after performing spinal anesthesia
|
For 12 hours after performing spinal anesthesia
|
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Duration of sensory blockade
Tidsram: For 12 hours after performing spinal anesthesia
|
For 12 hours after performing spinal anesthesia
|
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Duration of analgesia
Tidsram: 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
|
Cumulative consumption of analgesics
Tidsram: For 24 hours after performing spinal anesthesia
|
Total opioid or other analgesics received for the first 24 hours after surgery.
|
For 24 hours after performing spinal anesthesia
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Reem A El Sharkawy, MD, Lecturer of anesthesia and surgical intensive care
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Sår och skador
- Benskador
- Lårbensfrakturer
- Frakturer, ben
- Läkemedels fysiologiska effekter
- Depressiva medel i centrala nervsystemet
- Agenter från det perifera nervsystemet
- Analgetika
- Sensoriska systemagenter
- Bedövningsmedel, intravenöst
- Anestesimedel, general
- Bedövningsmedel
- Analgetika, Opioid
- Narkotika
- Adjuvans, anestesi
- Anestesimedel, lokal
- Fentanyl
- Bupivakain
Andra studie-ID-nummer
- MS/811
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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