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

Not Applicable

• Conditions: Low Ejection Fraction Patients; Fracture Tibia
• Interventions: Procedure: unilateral epidural anesthesia; Procedure: Ultrasound guided femoro/ sciatic nerve block

• Registration Number: NCT05506501
• Lead Sponsor: Ain Shams University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-15
• Study First Submitted QC: 2022-08-16
• Last Update Submitted: 2022-08-16
• Study First Posted: 2022-08-18
• Last Update Posted: 2022-08-18
• Study Start: 2022-09-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unilateral epidural anesthesia group	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.
Ultrasound guided femoro/ sciatic nerve block group	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.

Primary Outcome Measures

Name	Time	Method
mean blood pressure	20 minutes after anesthesia

Secondary Outcome Measures

Name	Time	Method
time of first analgesic request	within 24 hours after the block
adequate motor block	15 minutes after the block
adequate sensory block	20 minutes after the block

Trial Locations

Locations (1)

Ain shams university; 🇪🇬 Cairo, Egypt