Bilateral Erector Spinae Plane Block as an Opioid Sparing Technique for Selective Dorsal Rhizotomy in Pediatric Patients With Spastic Cerebral Palsy

NCT ID: NCT06600061

Last Updated: 2025-11-21

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

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-17

Study Completion Date

2025-10-15

Brief Summary

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This study aims to evaluate the efficacy of bilateral erector spinae plane block as an opioid-sparing technique for selective dorsal rhizotomy in pediatric patients with spastic cerebral palsy.

Detailed Description

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Cerebral palsy (CP) is the most common physical disability affecting children. Selective dorsal rhizotomy (SDR) is a neurosurgical procedure that permanently reduces lower limb spasticity in children with CP by selectively targeting and removing sensory rootlets with aberrant activity.

Postoperative pain is often distressing for patients and their families and can result in complications, delayed participation in therapy, and poor functional recovery. Erector spinae plane block (ESPB) is a newly described interfascial plane block. ESPB is effective on both visceral and somatic pain.

Conditions

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Erector Spinae Plane Block Opioid Sparing Selective Dorsal Rhizotomy Pediatric Spastic Cerebral Palsy

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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Erector Spinae Plane Block group

Patients will receive erector spinae plane block after induction of anesthesia.

Group Type EXPERIMENTAL

Erector Spinae Plane Block

Intervention Type OTHER

Patients will receive erector spinae plane block after induction of anesthesia.

Control group

Patients will not receive erector spinae plane block.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Erector Spinae Plane Block

Patients will receive erector spinae plane block after induction of anesthesia.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age from 6 to 18 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status II, III.
* Patients with spastic cerebral palsy undergoing selective dorsal rhizotomy.

Exclusion Criteria

* Allergy to local anesthetics.
* Severe fixed joint deformity.
* Previous orthopedic surgery.
* Patient with abnormal liver/kidney function.
* Patient with skin damage or infection at the proposed puncture site.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 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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Mohammed Said ElSharkawy

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University

Tanta, El-Gharbia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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36264PR838/9/24

Identifier Type: -

Identifier Source: org_study_id

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