Ultrasound-Guided Lumbar Erector Spinae Plane Block Versus Caudal Block for Postoperative Analgesia in Hip and Proximal Femur Surgery in Pediatric Patients

NCT ID: NCT05157516

Last Updated: 2022-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-21

Study Completion Date

2022-06-28

Brief Summary

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The study will compare Ultrasound-Guided Lumbar Erector Spinae Plane Block and caudal block for Postoperative Analgesia in Hip and Proximal Femur Surgery in pediatric patients

Detailed Description

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Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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group ESPB

Erector Spinae Plane Block

Group Type ACTIVE_COMPARATOR

erector spinea block

Intervention Type PROCEDURE

the patients will receive a single injection erector spinea block after induction of general anesthesia

In group CEA

Caudal epidural block

Group Type ACTIVE_COMPARATOR

Caudal epidural block

Intervention Type PROCEDURE

the patients will receive caudal epidural block after induction of general anesthesia

Interventions

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erector spinea block

the patients will receive a single injection erector spinea block after induction of general anesthesia

Intervention Type PROCEDURE

Caudal epidural block

the patients will receive caudal epidural block after induction of general anesthesia

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ASA I-II.
* Scheduled to undergo hip or proximal femur surgeries.

Exclusion Criteria

* Refusal of participation by parents or caregivers
* Known local anesthetic (LA) drug sensitivity
* Bleeding disorders with INR \> 1.5 and/or platelets \< 100,000/mm3.
* Skin lesions or wounds at the site of proposed needle insertion.
Minimum Eligible Age

1 Year

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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AbdElKhalik Mahmoud Shaban

Lecturer of anaesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kasr Alaini hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MD-340-2020

Identifier Type: -

Identifier Source: org_study_id

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