Actively Recruiting

Phase Not Applicable
Age: 3Months - 16Years
All Genders
ID07474909

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

Led by Poznan University of Medical Sciences · Updated on 2026-05-22

150

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the neurological safety and pain-relieving effects of dexamethasone given either around the nerve (perineurally) or through a vein (intravenously) as an add-on to a brachial plexus nerve block in children having hand or forearm surgery. This clinical trial aims to understand whether perineural dexamethasone causes nerve injury compared to intravenous dexamethasone or placebo. The study will also explore long-term safety, which has limited evidence especially for children. All participants will receive a single brachial plexus block with ropivacaine guided by ultrasound. They will be randomly assigned to one of three groups: perineural dexamethasone, intravenous dexamethasone, or placebo (normal saline) given both ways. The doses are weight-based with maximum limits. The trial is double-blind, meaning neither participants nor researchers know the group assignments. Treatment effects will be compared over a 12-month period. During the study, neurological function will be assessed through clinical exams and blood tests measuring serum neurofilament light chain, a marker for nerve damage. Researchers will also evaluate pain levels using standard scales, opioid use after surgery, and any adverse events. Follow-up will continue for 12 months to monitor nerve safety and recovery outcomes. This may help establish safe dosing and administration guidelines for dexamethasone in pediatric nerve blocks.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 3Months - 16Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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 greater than 99th percentile for age and sex
  • Pregnancy or breastfeeding
  • Participation in another interventional clinical trial within 30 days
  • Refusal of consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single day of surgery

Participants receive a brachial plexus block with ropivacaine combined with either perineural dexamethasone, intravenous dexamethasone, or placebo as part of their pediatric hand or forearm surgery.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - Up to 30 days after surgery

Participants are monitored for pain, opioid use, neurological integrity, and adverse events after surgery.

Multiple visits during the first 48 hours and additional follow-ups up to 30 days

Long-term Monitoring

Duration - Up to 12 months

Participants are followed for neurological safety and functional recovery including biomarker assessments for up to 12 months after surgery.

Periodic visits over 12 months

Trial Site Locations

Total: 1 location

1

Poznan University of Medical Sciences

Poznan, Poland, 62-701

Actively Recruiting

Loading map...

Research Team

M

Malgorzata Reysenr, MD PhD

M

Malgorzata Reysner, MD PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Similar Trials

Reconstruction of Chronic Scapholunate Ligament Injuries in ...

Ligament Injury

Actively Recruiting

2 locations

The Use of N-acetylcysteine Supplementation in Addition to N...

Carpal Tunnel Syndrome

Actively Recruiting

1 location

Determination of Factors Affecting Social Participation and ...

Hand Injuries

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here