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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06600061
Enrollment
30
Registered
2024-09-19
Start date
2024-09-17
Completion date
2025-10-15
Last updated
2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERErector Spinae Plane Block

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

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Total morphine consumption24 hours postoperativelyRescue 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

MeasureTime frameDescription
Time to the 1st rescue analgesia24 hours postoperativelyTime 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 pain24 hours postoperativelyEach 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 satisfaction24 hours postoperativelyDegree 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 events24 hours postoperativelyIncidence 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026