NCT07474909 Perineural vs Intravenous Dexamethasone as an Adjuvant to Brachial Plexus Block in Pediatric Hand Surgery
| NCT ID | NCT07474909 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Poznan University of Medical Sciences |
| Condition | Hand Injuries and Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-12-10 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2025-12-10 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Malgorzata Reysner, MD PhD
STUDY CHAIR
Poznan University of Medical Sciences
Frequently Asked Questions
Who can join the NCT07474909 clinical trial?
This trial is open to participants of all sexes, aged 3 Months or older, up to 16 Years, studying Hand Injuries and Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07474909 currently recruiting?
Yes, NCT07474909 is actively recruiting participants. Contact the research team at mreysner@ump.edu.pl for enrollment information.
Where is the NCT07474909 trial being conducted?
This trial is being conducted at Poznan, Poland.
Who is sponsoring the NCT07474909 clinical trial?
NCT07474909 is sponsored by Poznan University of Medical Sciences. The principal investigator is Malgorzata Reysner, MD PhD at Poznan University of Medical Sciences. The trial plans to enroll 150 participants.