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

Not Applicable

Recruiting

• Conditions: Erector Spinae Plane Block; Opioid; Sparing; Selective Dorsal Rhizotomy; Pediatric; Spastic Cerebral Palsy
• Interventions: Other: Erector Spinae Plane Block

• Registration Number: NCT06600061
• Lead Sponsor: Tanta University

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-12
• Study Start: 2024-09-17
• Study First Submitted QC: 2024-09-17
• Last Update Submitted: 2024-09-17
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erector Spinae Plane Block group	Erector Spinae Plane Block	Patients will receive erector spinae plane block after induction of anesthesia.

Primary Outcome Measures

Name	Time	Method
Total morphine consumption	24 hours postoperatively	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.

Secondary Outcome Measures

Name	Time	Method
Time to the 1st rescue analgesia	24 hours postoperatively	Time to the first request for the rescue analgesia (time from end of surgery to the first dose of morphine administrated) will be assessed.
Degree of pain	24 hours postoperatively	Each patient will be instructed about postoperative pain assessment with the Wong-Baker pain rating scale (The scale contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts worst"). Wong-Baker score will be assessed at post anesthesia care unit, 4, 6, 8, 12, 18 and 24 h postoperatively.
Patient satisfaction	24 hours postoperatively	Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)
Incidence of adverse events	24 hours postoperatively	Incidence of adverse events such as Local anesthetic systemic toxicity (LAST), bradycardia, hypotension, postoperative nausea and vomiting (PONV), respiratory depression, or any other complication will be recorded.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt