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Ultrasound-Guided Fascia Iliaca Compartmental Block Versus Spinal Anesthesia in Femoral Thrombectomy

NCT ID: NCT06745986

Last Updated: 2024-12-24

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-13

Study Completion Date

2021-05-01

Brief Summary

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This study aims to assess the efficiency of Fascia Iliaca Compartmental Block in patients undergoing femoral thrombectomy versus spinal anesthesia.

Detailed Description

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Anesthesia for lower limb revascularization consists of general anesthesia, neuraxial anesthesia and peripheral regional block. Fascia iliaca compartment block (FICB) is an anterior approach to the lumbar plexus and it blocks femoral nerve, LFCN, and limited numbers of nearby nerves such as ilioinguinal, genitor femoral.

Conditions

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Fascia Iliaca Compartmental Block Femoral Thrombectomy Spinal Anesthesia

Keywords

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Visual Analogue Score UltraSound Guided Fascia Iliaca Compartmental Block, Spinal Anesthesia, Femoral Thrombectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Eighty-four cases were scheduled for femoral thrombectomy and classified into tw0 equal groups (n=42 each), spinal group received spinal anesthesia with 0.5% hyperbaric bupivacaine in a total volume in a total volume 2.5ml and fascia iliaca group received ultrasound guided fascia iliaca block with 40ml of 0.25% bupivacaine for each block. Data collected for each block were onset and duration of sensory and motor block, visual analogue scale, analgesic duration and analgesic consumption, hemodynamics and complications.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fascia iliaca group

The ultrasound-guided fascia iliaca compartment block (FICB) group included 42 patients who had a fascia iliaca compartment block by bupivacaine 0.25% in a total volume of 40 ml.

Group Type ACTIVE_COMPARATOR

ultrasound guided fascia iliaca compartment block ( bupivacaine 0.25% )

Intervention Type DRUG

Fascia iliaca compartment block by bupivacaine 0.25% in a total volume of 40 ml.

spinal anesthesia

spinal anesthesia included 42 patients had spinal anesthesia with 2.5 ml bupivacaine 0.5%.

Group Type ACTIVE_COMPARATOR

Spinal Anesthesia (bupivacaine)

Intervention Type DRUG

spinal anesthesia by 2.5 ml bupivacaine 0.5%

Interventions

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ultrasound guided fascia iliaca compartment block ( bupivacaine 0.25% )

Fascia iliaca compartment block by bupivacaine 0.25% in a total volume of 40 ml.

Intervention Type DRUG

Spinal Anesthesia (bupivacaine)

spinal anesthesia by 2.5 ml bupivacaine 0.5%

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* scheduled femoral thrombectomy,
* both sexes,
* aged between 40-65 years,
* American Society of Anesthesiologists (ASA) II-III. Patients Criteria:

Exclusion Criteria

* ASA status Grade IV, patient
* refused to participate,
* patients with contraindications to neuraxial anesthesia, such as systemic infection or history of allergy to anesthetic drugs
* infection at the site of injection.
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Port Said University hospital

OTHER

Sponsor Role lead

Responsible Party

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Adel Ali Hassan

Lecturer of anaesthesiai ntensivecare and pain managment

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mansoura university hosbital

New Damietta, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MS/17.10.109

Identifier Type: -

Identifier Source: org_study_id