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

NCT07474909 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Hand Injuries and Disorders
  • Wrist Sprain

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.

Sponsors & Collaborators

  • Poznan University of Medical Sciences

    lead OTHER

Principal Investigators

  • Malgorzata Reysner, MD PhD · Poznan University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-10
Primary Completion
2027-01-01
Completion
2027-01-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07474909 on ClinicalTrials.gov