About this trial
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.
Eligibility criteria
Qualifiers
Age 3 months to 16 years
Scheduled elective hand or forearm surgery under general anesthesia with a brachial plexus block
ASA physical status I-III
Planned use of ultrasound-guided regional anesthesia
Disqualifiers
Pre-existing neurological disease or peripheral neuropathy
Preoperative sensory deficit in the operative limb
Infection at or near the needle insertion site
Coagulopathy or therapeutic anticoagulation
Trial design
Treatments tested in this trial
- iv dexamethasone
- pn dexamethasone
- 0.9%NaCl