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

NCT05506501 | Unknown

• 1 other identifier: OFT IRB00006379
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Ejection Fraction Patients; Fracture Tibia

Outcome Measures

Primary Outcomes (1)

• mean blood pressure

  20 minutes after anesthesia

Secondary Outcomes (3)

• adequate sensory block

  20 minutes after the block

• adequate motor block

  15 minutes after the block

• time of first analgesic request

  within 24 hours after the block

Study Arms (2)

Unilateral epidural anesthesia group

ACTIVE COMPARATOR

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.

Procedure: unilateral epidural anesthesia

Ultrasound guided femoro/ sciatic nerve block group

ACTIVE COMPARATOR

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.

Procedure: Ultrasound guided femoro/ sciatic nerve block

Interventions

unilateral epidural anesthesia 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.

Also known as: Ultrasound guided femoro/ sciatic nerve block

Unilateral epidural anesthesia group

Ultrasound guided femoro/ sciatic nerve block 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.

Ultrasound guided femoro/ sciatic nerve block group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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%).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, 20, Egypt

Location

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 18, 2022
• Study Start: September 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)