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Recruiting NCT07474909

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

No phase Interventional Hand Injuries and Disorders Wrist Sprain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: iv dexamethasone, pn dexamethasone, 0.9%NaCl.
Who it may be relevant to
Registry conditions: Hand Injuries and Disorders, Wrist Sprain. Basic parameters: 3 months — 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparison of Perineural Versus Intravenous Dexamethasone as an Adjuvant to Brachial Plexus Block in Pediatric Hand and Forearm Surgery: A Randomized Double-Blind Placebo-Controlled Trial With Neurological Safety Evaluation and Neurofilament Light Chain Biomarker Assessment

Overview

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

  • Drug iv 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.
  • Drug pn 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.
  • Drug 0.9%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.

Primary outcome measures

  • Incidence of Persistent Neurological Deficit [Time frame: up to 12 months]
Secondary outcome measures (12)
  • Time to First rescue analgesia [Time frame: Within 0-48 hours after surgery.]
  • Total Opioid Consumption [Time frame: 0-48 hours after surgery.]
  • Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale [Time frame: Post-anesthesia care unit (PACU), 2 hours after surgery.]
  • Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale [Time frame: Post-anesthesia care unit (PACU), 6 hours after surgery.]
  • Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale [Time frame: Post-anesthesia care unit (PACU), 12 hours after surgery.]
  • Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale [Time frame: Post-anesthesia care unit (PACU), 24 hours after surgery.]
  • Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale [Time frame: Post-anesthesia care unit (PACU), 48 hours after surgery.]
  • Postoperative pain intensity assessed with the Numerical Rating Scale (NRS) [Time frame: Post-anesthesia care unit (PACU), 2 hours after surgery.]
  • Postoperative pain intensity assessed with the Numerical Rating Scale (NRS) [Time frame: Post-anesthesia care unit (PACU), 6 hours after surgery.]
  • Postoperative pain intensity assessed with the Numerical Rating Scale (NRS) [Time frame: Post-anesthesia care unit (PACU), 12 hours after surgery.]
  • Postoperative pain intensity assessed with the Numerical Rating Scale (NRS) [Time frame: Post-anesthesia care unit (PACU), 24 hours after surgery.]
  • Postoperative pain intensity assessed with the Numerical Rating Scale (NRS) [Time frame: Post-anesthesia care unit (PACU), 48 hours after surgery.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Poland · 1 center
  • Poznan University of Medical Sciences — Poznan

Identifiers

NCT: NCT07474909 · 12_2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗