Conventional Caudal Block, Ultrasound Guided Caudal Block and Ultrasound Guided Erector Spinae Block for Pediatric Hip Surgery

NCT ID: NCT04712370

Last Updated: 2021-01-20

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-16

Study Completion Date

2021-09-10

Brief Summary

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This study will be conducted to compare the efficacy and safety of ultrasound guided erector spinae block , ultrasound guided caudal block and conventional caudal block for pain management after pediatric hip surgery.

Detailed Description

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Conditions

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Conventional Caudal Block Ultrasound Guided Caudal Block Ultrasound Guided Erector Spinae Block Pediatric Hip Surgery

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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Conventional caudal block

Patients of this group will receive the conventional method (blind technique without ultrasound) of caudal block

Group Type ACTIVE_COMPARATOR

Conventional caudal block

Intervention Type PROCEDURE

Patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected in the caudal epidural space) by the conventional method (blind technique without ultrasound).

Ultrasound-guided caudal block

Patients of this group will receive caudal block using ultrasound.

Group Type EXPERIMENTAL

Ultrasound-guided caudal block

Intervention Type PROCEDURE

Using ultrasound, patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected in the caudal epidural space).

Ultrasound guided erector spinae plane Block

Patients of this group will receive ultrasound guided erector spinae plane Block at the level of the transverse process of the second lumbar vertebrae(L2) .

Group Type EXPERIMENTAL

Ultrasound guided erector spinae plane Block

Intervention Type PROCEDURE

Under ultrasound guidance, patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath) at the level of the transverse process of the second lumbar vertebrae(L2).

Interventions

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Conventional caudal block

Patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected in the caudal epidural space) by the conventional method (blind technique without ultrasound).

Intervention Type PROCEDURE

Ultrasound-guided caudal block

Using ultrasound, patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected in the caudal epidural space).

Intervention Type PROCEDURE

Ultrasound guided erector spinae plane Block

Under ultrasound guidance, patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath) at the level of the transverse process of the second lumbar vertebrae(L2).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Both sex
* ASA physical activity I, II
* Age 4-12 years
* Admitted for elective hip surgery.

Exclusion Criteria

* Parents refusal
* Children with severe systemic disease
* ASA III or IV
* Children with previous neurological or spinal anomaly, coagulation disorders
* History of premature birth
* Infection at the block injection site
* History of allergy to local anesthetics
* Bilateral hip surgery.
Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Eman Hamdy Abu-Shanab

Principal Investigator and Assistant lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University Hospitals

Tanta, ElGharbiaa, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Eman Hamdy Abu-Shanab, MSc

Role: CONTACT

+201005518097

Facility Contacts

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Eman Hamdy Abu-Shanab

Role: primary

+201005518097

Other Identifiers

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33143/05/19

Identifier Type: -

Identifier Source: org_study_id

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