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.
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
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
Parallel
iv dexamethasone
DrugParticipants in this arm will receive intravenous dexamethasone at a dose of 0.1 mg/kg (maximum 8 mg) administered immediately before the brachial plexus block. A perineural placebo (0.9% normal saline) will be added to the local anesthetic syringe for the nerve block in order to maintain blinding.
pn dexamethasone
DrugParticipants in this arm will receive dexamethasone administered perineurally at a dose of 0.1 mg/kg (maximum 4 mg) mixed with the local anesthetic solution for the brachial plexus block. An intravenous placebo (0.9% normal saline) will be administered immediately before the block to maintain blinding.
0.9%NaCl
DrugParticipants in this arm will receive placebo both intravenously and perineurally. Normal saline will be added to the local anesthetic solution for the brachial plexus block and administered intravenously in volumes matching the active treatment groups in order to maintain blinding.
Incidence of Persistent Neurological Deficit
Incidence of sensory or motor neurological deficit attributed to the block that persists ≥3 months postoperatively.
Time to First rescue analgesia
Time (in hours) from completion of the brachial plexus block to the first self-reported painful sensation requiring administration of analgesic medication.
Total Opioid Consumption
Total cumulative opioid dose administered postoperatively, converted to oral morphine milligram equivalents (MME) and normalized to body weight (mg/kg).
Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale
Postoperative pain intensity will be assessed in younger children using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The FLACC scale ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the most severe pain. Higher scores indicate worse pain. Mean FLACC scores will be compared between treatment groups.
Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale
Postoperative pain intensity will be assessed in younger children using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The FLACC scale ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the most severe pain. Higher scores indicate worse pain. Mean FLACC scores will be compared between treatment groups.
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