Hand Injuries and Disorders, Wrist Sprain
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGiv dexamethasone
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.
DRUGpn dexamethasone
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.
DRUG0.9%NaCl
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.
Sponsors
Poznan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Months to 16 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Written informed consent from parent(s) or legal guardian and age-appropriate assent from the child
Exclusion criteria
* 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 * Systemic infection or sepsis * Chronic steroid therapy within 30 days before surgery * Known allergy to ropivacaine or dexamethasone * Diabetes mellitus * BMI \> 99th percentile for age and sex. * Pregnancy or breastfeeding * Participation in another interventional clinical trial within 30 days * Refusal of consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Persistent Neurological Deficit | up to 12 months | Incidence of sensory or motor neurological deficit attributed to the block that persists ≥3 months postoperatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First rescue analgesia | Within 0-48 hours after surgery. | Time (in hours) from completion of the brachial plexus block to the first self-reported painful sensation requiring administration of analgesic medication. |
| Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale | Post-anesthesia care unit (PACU), 2 hours after surgery. | 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 Numerical Rating Scale (NRS) | Post-anesthesia care unit (PACU), 2 hours after surgery. | 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. |
| Adverse Events | Up to 30 days after surgery. | Incidence of adverse events potentially related to the nerve block, including postoperative nausea and vomiting (PONV), hematoma, infection, or local anesthetic systemic toxicity (LAST). |
| Incidence of perioperative hyperglycemia | Up to 24 hours after surgery. | 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. |
| Total Opioid Consumption | 0-48 hours after surgery. | Total cumulative opioid dose administered postoperatively, converted to oral morphine milligram equivalents (MME) and normalized to body weight (mg/kg). |
Contacts
CONTACTMalgorzata Reysenr, MD PhD
CONTACTMalgorzata Reysner, MD PhD
STUDY_CHAIRMalgorzata Reysner, MD PhD
Poznan University of Medical Sciences
Outcome results
None listed