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Comparison of Perineural Versus Intravenous Dexamethasone as an Adjuvant to Brachial Plexus Block in Pediatric Hand and Forearm Surgery: A Randomized Double-Blind Placebo-Controlled Trial With Neurological Safety Evaluation and Neurofilament Light Chain Biomarker Assessment
This clinical trial will evaluate the neurological safety and analgesic effectiveness of dexamethasone administered perineurally or intravenously as an adjuvant to brachial plexus block in children undergoing hand or forearm surgery. Dexamethasone is commonly used to prolong the duration of regional anesthesia, but there is limited evidence on long-term neurological safety, particularly in pediatric patients. All participants will receive a single-shot brachial plexus block using ropivacaine under ultrasound guidance. Patients will be randomized into one of three treatment groups: perineural dexamethasone, intravenous dexamethasone, or placebo. The primary objective is to determine whether perineural dexamethasone causes any clinically significant nerve injury compared with intravenous administration or placebo. Neurological function will be assessed clinically and via serum neurofilament light chain (NfL) levels over a 12-month follow-up period. This study may provide evidence regarding the long-term safety profile of perineural dexamethasone in children and help establish evidence-based dosing and administration guidelines.
Regional anesthesia using brachial plexus block is routinely used for pediatric upper limb surgery, but the long-term neurological safety of perineural dexamethasone remains uncertain. Previous adult studies and early pilot investigations suggest that dexamethasone increases the duration of analgesia and may reduce opioid requirements, but pediatric data remain scarce. This randomized double-blind placebo-controlled clinical trial will compare three approaches: perineural dexamethasone, intravenous dexamethasone, placebo. Neurological integrity will be evaluated using structured neurological examinations and serial measurement of serum neurofilament light chain (NfL), a biomarker of peripheral nerve damage. Functional recovery, pain scores, opioid use, and adverse events will also be assessed. Each patient will be followed for 12 months. The results may guide pediatric regional anesthesia practice and help determine whether perineural dexamethasone is safe with regard to neurologic sequelae.
Age
0 - 16 years
Sex
ALL
Healthy Volunteers
No
Start Date
April 1, 2026
Primary Completion Date
January 1, 2027
Completion Date
January 31, 2027
Last Updated
March 16, 2026
150
ESTIMATED participants
iv dexamethasone
DRUG
pn dexamethasone
DRUG
0.9%NaCl
DRUG
Lead Sponsor
Poznan University of Medical Sciences
NCT04460521
NCT04646343
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06155617