Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
60 participants
INTERVENTIONAL
2019-05-31
2019-12-31
Brief Summary
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The primary outcome will be the duration of effective analgesia from FICB till the first analgesic dose is required,the secondary outcomes will be the severity of postoperative pain as will be assessed by the visual analogue scale and the total dose of pethidin for rescue analgesia.
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Detailed Description
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FICB is believed to be most beneficial compared to other procedures because of its safety and efficacy . FICB provides blockage of at least two of the three major nerves that supply the medial, anterior and lateral thigh with one simple injection, namely the femoral and lateral femoral cutaneous nerves.
FICB is an anterior approach to the lumbar plexus. The pop technique using fascial click had a low success rate of 35% - 47% .However, as the FICB was performed under real-time ultrasound guidance, the success rate was increased up to 82- 87%, leading to an increased interest in FICB as a postoperative analgesia option for hip and knee surgical procedures .
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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the control group
Ultrasound guided fascia iliaca compartment block (FICB) will be performed using 28 ml bupivacaine 0.25% + 2 ml of normal saline (total volume 30 ml).(
Bupivacaine
Ultrasound guided fascia iliaca compartment block (FICB) will be performed using 28 ml bupivacaine 0.25% + 2 ml of normal saline (total volume 30 ml).(
Group dexamethasone/Bupivacaine:
Ultrasound guided fascia iliaca compartment block (FICB) will be performed using with 28 ml bupivacaine 0.25% + 2 ml dexamethasone (8mg) (total volume 30 ml).(
Dexamethasone/bupivacaine
Ultrasound guided fascia iliaca compartment block (FICB) will be performed with 28 ml bupivacaine 0.25% + 2 ml dexamethasone (8mg) (total volume 30 ml)d using
Group Magnesium sulphate/Bupivacaine
Ultrasound guided fascia iliaca compartment block (FICB) will be performed using 28 ml bupivacaine 0.25% + 2 ml magnesium sulphate (200mg) (total volume 30 ml).
Magnesium Sulfate/bupivacaine
Ultrasound guided fascia iliaca compartment block (FICB) will be performed using 28 ml bupivacaine 0.25% + 2 ml magnesium sulphate (200mg) (total volume 30 ml).
Interventions
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Bupivacaine
Ultrasound guided fascia iliaca compartment block (FICB) will be performed using 28 ml bupivacaine 0.25% + 2 ml of normal saline (total volume 30 ml).(
Dexamethasone/bupivacaine
Ultrasound guided fascia iliaca compartment block (FICB) will be performed with 28 ml bupivacaine 0.25% + 2 ml dexamethasone (8mg) (total volume 30 ml)d using
Magnesium Sulfate/bupivacaine
Ultrasound guided fascia iliaca compartment block (FICB) will be performed using 28 ml bupivacaine 0.25% + 2 ml magnesium sulphate (200mg) (total volume 30 ml).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age between 20 and 70 years.
* Patients with traumatic hip fracture presenting for elective or emergency dynamic hip screw (DHS) fixation under spinal anesthesia.
Exclusion Criteria
* Patients with history of allergy to dexamethasone, magnesium sulphate or bupivacaine.
* Patients with contraindications to spinal anesthesia.
* Previous surgery in the affected hip, infection at the injection site, multiple fractures.
* Peripheral neuropathy.
* Use of analgesics within 8 hours before the spinal block.
* Inguinal hernia, and femoral artery graft.
20 Years
70 Years
ALL
No
Sponsors
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Samaa Rashwan
OTHER
Responsible Party
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Samaa Rashwan
Principal Investigator
Principal Investigators
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Samaa Rashwan, MD
Role: PRINCIPAL_INVESTIGATOR
Assisstant proffesor of anesthesia
Locations
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Beni-Suef University Hospital
Banī Suwayf, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Samaa Rashwan, MD
Role: primary
Other Identifiers
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Beni-Suef Faculty of Medicine
Identifier Type: -
Identifier Source: org_study_id
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