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

NCT06600061 | Completed

• 1 other identifier: 36264PR838/9/24
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption

  Rescue analgesia of 0.05 mg/kg morphine will be given if the Wong-Baker score is 4 more to be repeated after 30 min if pain persists until the Wong-Baker score \< 4.

  24 hours postoperatively

Secondary Outcomes (4)

• Time to the 1st rescue analgesia

  24 hours postoperatively

• Degree of pain

  24 hours postoperatively

• Patient satisfaction

  24 hours postoperatively

• Incidence of adverse events

  24 hours postoperatively

Study Arms (2)

Erector Spinae Plane Block group

EXPERIMENTAL

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

Other: Erector Spinae Plane Block

Control group

NO INTERVENTION

Patients will not receive erector spinae plane block.

Interventions

Erector Spinae Plane Block OTHER

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

Erector Spinae Plane Block group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: September 17, 2024
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)