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

Comparative Study Between Intentional Unilateral Epidural Block Versus Ultrasound Guided Combined Femoro-sciatic Nerves Block for Patients With Low Ejection Fraction Undergoing Insertion of Nail Tibia for Fixation of Fracture Shaft Tibia

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05506501

Enrollment

Registered

2022-08-18

Start date

2022-09-01

Completion date

2023-01-01

Last updated

2022-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fracture Tibia, Low Ejection Fraction Patients

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.

Interventions

PROCEDUREunilateral 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.

PROCEDUREUltrasound 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
mean blood pressure	20 minutes after anesthesia

Secondary

Measure	Time frame
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026