Perineural vs Intravenous Dexamethasone as an Adjuvant to Brachial Plexus Block in Pediatric Hand Surgery

Poznan University of Medical Sciences (PUMS)

Status: Not yet enrolling

Conditions: Wrist Sprain; Hand Injuries and Disorders

Treatments: Drug: 0.9%NaCl; Drug: pn dexamethasone; Drug: iv dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT07474909

12_2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 3 months to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups

Intravenous Dexamethasone + Perineural Placebo

Active Comparator group

Description:

Brachial plexus block with ropivacaine + dexamethasone IV 0.1 mg/kg (max 8 mg) and perineural 0.9% NaCl.

Treatment:

Drug: iv dexamethasone

Perineural Dexamethasone + Intravenous Placebo

Active Comparator group

Description:

Brachial plexus block with ropivacaine + dexamethasone perineurally 0.1 mg/kg (max 4 mg) and IV 0.9% NaCl.

Treatment:

Drug: pn dexamethasone

Placebo (IV + Perineural)

Active Comparator group

Description:

Brachial plexus block with ropivacaine + 0.9% NaCl both IV and perineurally.

Treatment:

Drug: 0.9%NaCl