Unilateral Epidural Block Versus Ultrasound Guided Combined Femoro-sciatic Nerves Block for Patients With Low Ejection Fraction

NCT ID: NCT05506501

Last Updated: 2022-08-18

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-01-01

Brief Summary

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compare unilateral epidural anesthesia versus femoral/sciatic nerve block by ultrasound guided as anesthetic technique for cases with low ejection fraction undergoing insertion of nail tibia for fixation of fracture shaft tibia.

Detailed Description

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Group A ;( Unilateral epidural anesthesia group) Forty patients with low ejection fraction (30-40%) will do elective insertion of nail tibia for fixation of fracture shaft tibia using unilateral epidural anesthesia.

Group B;;( Ultrasound guided femoro/ sciatic nerve block group) Forty patients with low ejection fraction (30-40%) will do elective insertion of nail tibia for fixation of fracture shaft tibia by femoral/sciatic nerve block using ultrasound guidance.

For each patient, onset of sensory and motor block, degree of motor block, sign of sensory block in the contralateral lower limb for the epidural group, success in providing adequate anesthesia, hemodynamic changes, time of first analgesic request will be recorded.

Conditions

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Low Ejection Fraction Patients Fracture Tibia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Unilateral epidural anesthesia group

Forty patients with low ejection fraction (30-40%) will do elective insertion of nail tibia for fixation of fracture shaft tibia using unilateral epidural anesthesia.

Group Type ACTIVE_COMPARATOR

unilateral epidural anesthesia

Intervention Type PROCEDURE

Forty patients with low ejection fraction (30-40%) will do elective insertion of nail tibia for fixation of fracture shaft tibia using unilateral epidural anesthesia.

Ultrasound guided femoro/ sciatic nerve block group

Forty patients with low ejection fraction (30-40%) will do elective insertion of nail tibia for fixation of fracture shaft tibia by femoral/sciatic nerve block using ultrasound guidance.

Group Type ACTIVE_COMPARATOR

Ultrasound guided femoro/ sciatic nerve block

Intervention Type PROCEDURE

Forty patients with low ejection fraction (30-40%) will do elective insertion of nail tibia for fixation of fracture shaft tibia by femoral/sciatic nerve block using ultrasound guidance.

Interventions

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unilateral epidural anesthesia

Forty patients with low ejection fraction (30-40%) will do elective insertion of nail tibia for fixation of fracture shaft tibia using unilateral epidural anesthesia.

Intervention Type PROCEDURE

Ultrasound guided femoro/ sciatic nerve block

Forty patients with low ejection fraction (30-40%) will do elective insertion of nail tibia for fixation of fracture shaft tibia by femoral/sciatic nerve block using ultrasound guidance.

Intervention Type PROCEDURE

Other Intervention Names

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Ultrasound guided femoro/ sciatic nerve block

Eligibility Criteria

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Inclusion Criteria

* Age 18 to 60 years old.
* Patients scheduled for elective insertion of nail tibia for fixation of fracture shaft tibia.
* Patients with low ejection fraction (30-40%).

Exclusion Criteria

* Patient refusal
* Uncooperative patient
* Unconscious patients
* Cases with head trauma
* History of relevant drug allergy to local anesthetics
* Local infection at the site of the block
* Patients with coagulopathies and impaired platelet functions
* Patients with hemodynamic instability
* Previous neurological deficit in lower limb and previous femoral artery grafts or injuries.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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RAMY AHMED

Assistant Professor of Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain shams university

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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OFT IRB00006379

Identifier Type: -

Identifier Source: org_study_id

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