Perineural vs IV Dexamethasone to Improve Hand Surgery Anesthesia in Kids
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
Run by Poznan University of Medical Sciences · NCT07474909 · Data updated 2026-11-12
This study tests whether giving dexamethasone around the nerves or by IV helps kids recover from hand or forearm surgery with fewer pain and longer-lasting relief, compared to placebo.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Months to 16 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Poznan University of Medical Sciences Academic / other |
| Locations | 1 site (Poznan) |
| Status | Recruiting |
| Started | December 10, 2025 |
| Main results expected | January 1, 2027 |
| Study ends | January 31, 2027 |
| Registry record updated | May 22, 2026 |
| Trial ID | NCT07474909 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children 3 months to 16 years undergoing elective hand or forearm surgery with a planned ultrasound-guided brachial plexus block, without pre-existing neurological issues and meeting consent criteria.
✕Probably not a fit
Children with pre-existing neurological conditions, infections at the injection site, coagulopathy, systemic infection, or other exclusion criteria may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this randomized, double-blind study, children aged 3 months to 16 years undergoing elective hand or forearm surgery will receive a brachial plexus block with ropivacaine and be assigned to perineural dexamethasone, intravenous dexamethasone, or placebo. Researchers will assess long-term neurological safety using clinical exams and serum neurofilament light chain over 12 months, along with pain scores, opioid use, functional recovery, and adverse events. The trial aims to determine if perineural dexamethasone is safe for nerves in pediatric patients and whether it provides analgesic benefits beyond IV dexamethasone or placebo. Results could influence pediatric regional anesthesia practice and dosing strategies.
Why it matters
Potential benefit: If safe and effective, perineural dexamethasone could prolong analgesia and reduce opioid needs after hand surgery in children.
How similar studies have gone: Previous adult and early pediatric data suggest dexamethasone can extend analgesia, but pediatric long-term neuro safety data are limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Poznan University of Medical Sciences
Poznan, Poland Recruiting
Study contacts
- Study coordinator: Malgorzata Reysenr, MD PhD
- Email: mreysner@ump.edu.pl
- Phone: 48618738313
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.