Perineural vs Intravenous Dexamethasone as an Adjuvant to Brachial Plexus Block in Pediatric Hand… (NCT07474909) | Clinical Trial Compass
RecruitingNot Applicable
Perineural vs Intravenous Dexamethasone as an Adjuvant to Brachial Plexus Block in Pediatric Hand Surgery
Poland150 participantsStarted 2025-12-10
Plain-language 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.
Who can participate
Age range
3 Months – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.