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Status unknownNCT05506501Updated Aug 18, 2022

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

An interventional study of unilateral epidural anesthesia and Ultrasound guided femoro/ sciatic nerve block in Low Ejection Fraction Patients and Fracture Tibia, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-08-18.

Sponsored by Ain Shams University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Low Ejection Fraction Patients
  • Fracture Tibia

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03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's planned enrollment of 80 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    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.

    Procedure: unilateral epidural anesthesia

  • Active comparator
    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.

    Procedure: Ultrasound guided femoro/ sciatic nerve block

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.

    Also known as: Ultrasound guided femoro/ sciatic nerve block

  • 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.

06

What researchers measure

Primary outcomes

  1. mean blood pressure

    Time frame: 20 minutes after anesthesia

Secondary outcomes

  1. adequate sensory block

    Time frame: 20 minutes after the block

  2. adequate motor block

    Time frame: 15 minutes after the block

  3. time of first analgesic request

    Time frame: within 24 hours after the block

07

Study locations

1 site
  • Ain shams university
    Cairo, 20, Egypt
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05506501
Lead sponsor
Ain Shams University
Responsible party
RAMY AHMED (Assistant Professor of Anesthesia, Ain Shams University) — Principal investigator
First posted
Aug 18, 2022
Start date
Sep 1, 2022 (estimated)
Primary completion
Jan 1, 2023 (estimated)
Completion
Jan 1, 2023 (estimated)
Last update
Aug 18, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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