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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
Participants 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.
Participants 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.
Participants 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 frame: up to 12 months
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.
Time frame: Within 0-48 hours after surgery.
Total Opioid Consumption
Total cumulative opioid dose administered postoperatively, converted to oral morphine milligram equivalents (MME) and normalized to body weight (mg/kg).
Time frame: 0-48 hours after surgery.
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.
Time frame: Post-anesthesia care unit (PACU), 2 hours after surgery.
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.
Time frame: Post-anesthesia care unit (PACU), 6 hours after surgery.
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.
Time frame: Post-anesthesia care unit (PACU), 12 hours after surgery.
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.
Time frame: Post-anesthesia care unit (PACU), 24 hours after surgery.
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.
Time frame: Post-anesthesia care unit (PACU), 48 hours after surgery.
Postoperative pain intensity assessed with the Numerical Rating Scale (NRS)
Postoperative pain intensity will be assessed in adolescents using the Numerical Rating Scale (NRS). The NRS ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. Mean NRS scores will be compared between treatment groups.
Time frame: Post-anesthesia care unit (PACU), 2 hours after surgery.
Postoperative pain intensity assessed with the Numerical Rating Scale (NRS)
Postoperative pain intensity will be assessed in adolescents using the Numerical Rating Scale (NRS). The NRS ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. Mean NRS scores will be compared between treatment groups.
Time frame: Post-anesthesia care unit (PACU), 6 hours after surgery.
Postoperative pain intensity assessed with the Numerical Rating Scale (NRS)
Postoperative pain intensity will be assessed in adolescents using the Numerical Rating Scale (NRS). The NRS ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. Mean NRS scores will be compared between treatment groups.
Time frame: Post-anesthesia care unit (PACU), 12 hours after surgery.
Postoperative pain intensity assessed with the Numerical Rating Scale (NRS)
Postoperative pain intensity will be assessed in adolescents using the Numerical Rating Scale (NRS). The NRS ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. Mean NRS scores will be compared between treatment groups.
Time frame: Post-anesthesia care unit (PACU), 24 hours after surgery.
Postoperative pain intensity assessed with the Numerical Rating Scale (NRS)
Postoperative pain intensity will be assessed in adolescents using the Numerical Rating Scale (NRS). The NRS ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. Mean NRS scores will be compared between treatment groups.
Time frame: Post-anesthesia care unit (PACU), 48 hours after surgery.
Adverse Events
Incidence of adverse events potentially related to the nerve block, including postoperative nausea and vomiting (PONV), hematoma, infection, or local anesthetic systemic toxicity (LAST).
Time frame: Up to 30 days after surgery.
Incidence of perioperative hyperglycemia
Incidence of perioperative hyperglycemia, defined as blood glucose concentration \>180 mg/dL (10 mmol/L), measured to evaluate potential systemic metabolic effects of dexamethasone or placebo administration. The proportion of patients who meet the hyperglycemia threshold will be compared between groups.
Time frame: Up to 24 hours after surgery.
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