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

Primary Purpose

Low Ejection Fraction Patients, Fracture Tibia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
unilateral epidural anesthesia
Ultrasound guided femoro/ sciatic nerve block
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Low Ejection Fraction Patients

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Ain shams university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Unilateral epidural anesthesia group

Ultrasound guided femoro/ sciatic nerve block group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

mean blood pressure

Secondary Outcome Measures

adequate sensory block
adequate motor block
time of first analgesic request

Full Information

First Posted
August 15, 2022
Last Updated
August 16, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05506501
Brief Title
Unilateral Epidural Block Versus Ultrasound Guided Combined Femoro-sciatic Nerves Block for Patients With Low Ejection Fraction
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Ejection Fraction Patients, Fracture Tibia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Unilateral epidural anesthesia group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Ultrasound guided femoro/ sciatic nerve block group
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
unilateral epidural anesthesia
Other Intervention Name(s)
Ultrasound guided femoro/ sciatic nerve block
Intervention Description
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
Intervention Name(s)
Ultrasound guided femoro/ sciatic nerve block
Intervention Description
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 Measure Information:
Title
mean blood pressure
Time Frame
20 minutes after anesthesia
Secondary Outcome Measure Information:
Title
adequate sensory block
Time Frame
20 minutes after the block
Title
adequate motor block
Time Frame
15 minutes after the block
Title
time of first analgesic request
Time Frame
within 24 hours after the block

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ain shams university
City
Cairo
ZIP/Postal Code
20
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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