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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-16
SponsorPoznan University of Medical Sciences

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • iv dexamethasone
  • pn dexamethasone
  • 0.9%NaCl

Treatment groups

150 Participants
are divided into 3 treatment groups