Perineural vs Intravenous Dexamethasone as an Adjuvant to Brachial Plexus Block in Pediatric Hand Surgery
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Hand Injuries and Disorders, Wrist Sprain
In brief
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.
Key facts
- Study ID
- NCT07474909
- Run by
- Poznan University of Medical Sciences
- People needed
- 150
- Starts
- 2025-12-10
- Expected to finish
- 2027-01-31
- Last updated by the study team
- 2026-05-22
Who can join
Age: 0 and older, up to 16. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Poznan University of Medical Sciences — Poznan, Poland (enrolling)
Full record on ClinicalTrials.gov
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