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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hand Injuries and Disorders; Wrist Sprain
• Intervention / Treatment: Drug: iv dexamethasone; Drug: pn dexamethasone; Drug: 0.9%NaCl

Detailed Description

Regional anesthesia using brachial plexus block is routinely used for pediatric upper limb surgery, but the long-term neurological safety of perineural dexamethasone remains uncertain. Previous adult studies and early pilot investigations suggest that dexamethasone increases the duration of analgesia and may reduce opioid requirements, but pediatric data remain scarce.

This randomized double-blind placebo-controlled clinical trial will compare three approaches:

perineural dexamethasone, intravenous dexamethasone, placebo. Neurological integrity will be evaluated using structured neurological examinations and serial measurement of serum neurofilament light chain (NfL), a biomarker of peripheral nerve damage. Functional recovery, pain scores, opioid use, and adverse events will also be assessed. Each patient will be followed for 12 months.

The results may guide pediatric regional anesthesia practice and help determine whether perineural dexamethasone is safe with regard to neurologic sequelae.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Malgorzata Reysenr, MD PhD; Phone Number: 48618738313; Email: mreysner@ump.edu.pl
• Study Contact Backup: Name: Malgorzata Reysner, MD PhD; Phone Number: 48618738313; Email: mreysner@ump.edu.pl

Study Locations

• Poland
  • Poznan, Poland, 62-701
    • Recruiting
    • Poznan University of Medical Sciences
    • Contact: Malgorzata Reysner, M.D. Ph.D.; Phone Number: +48 61 873 83 03; Email: mreysner@ump.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intravenous Dexamethasone + Perineural Placebo; Brachial plexus block with ropivacaine + dexamethasone IV 0.1 mg/kg (max 8 mg) and perineural 0.9% NaCl.	Drug: iv dexamethasone; Participants in this arm will receive intravenous dexamethasone at a dose of 0.1 mg/kg (maximum 8 mg) administered immediately before the brachial plexus block. A perineural placebo (0.9% normal saline) will be added to the local anesthetic syringe for the nerve block in order to maintain blinding.
Active Comparator: Perineural Dexamethasone + Intravenous Placebo; Brachial plexus block with ropivacaine + dexamethasone perineurally 0.1 mg/kg (max 4 mg) and IV 0.9% NaCl.	Drug: pn dexamethasone; Participants in this arm will receive dexamethasone administered perineurally at a dose of 0.1 mg/kg (maximum 4 mg) mixed with the local anesthetic solution for the brachial plexus block. An intravenous placebo (0.9% normal saline) will be administered immediately before the block to maintain blinding.
Active Comparator: Placebo (IV + Perineural); Brachial plexus block with ropivacaine + 0.9% NaCl both IV and perineurally.	Drug: 0.9%NaCl; Participants in this arm will receive placebo both intravenously and perineurally. Normal saline will be added to the local anesthetic solution for the brachial plexus block and administered intravenously in volumes matching the active treatment groups in order to maintain blinding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Persistent Neurological Deficit	Incidence of sensory or motor neurological deficit attributed to the block that persists ≥3 months postoperatively.	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First rescue analgesia	Time (in hours) from completion of the brachial plexus block to the first self-reported painful sensation requiring administration of analgesic medication.	Within 0-48 hours after surgery.
Total Opioid Consumption	Total cumulative opioid dose administered postoperatively, converted to oral morphine milligram equivalents (MME) and normalized to body weight (mg/kg).	0-48 hours after surgery.
Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale	Postoperative pain intensity will be assessed in younger children using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The FLACC scale ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the most severe pain. Higher scores indicate worse pain. Mean FLACC scores will be compared between treatment groups.	Post-anesthesia care unit (PACU), 2 hours after surgery.
Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale	Postoperative pain intensity will be assessed in younger children using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The FLACC scale ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the most severe pain. Higher scores indicate worse pain. Mean FLACC scores will be compared between treatment groups.	Post-anesthesia care unit (PACU), 6 hours after surgery.
Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale	Postoperative pain intensity will be assessed in younger children using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The FLACC scale ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the most severe pain. Higher scores indicate worse pain. Mean FLACC scores will be compared between treatment groups.	Post-anesthesia care unit (PACU), 12 hours after surgery.
Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale	Postoperative pain intensity will be assessed in younger children using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The FLACC scale ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the most severe pain. Higher scores indicate worse pain. Mean FLACC scores will be compared between treatment groups.	Post-anesthesia care unit (PACU), 24 hours after surgery.
Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale	Postoperative pain intensity will be assessed in younger children using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The FLACC scale ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the most severe pain. Higher scores indicate worse pain. Mean FLACC scores will be compared between treatment groups.	Post-anesthesia care unit (PACU), 48 hours after surgery.
Postoperative pain intensity assessed with the Numerical Rating Scale (NRS)	Postoperative pain intensity will be assessed in adolescents using the Numerical Rating Scale (NRS). The NRS ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. Mean NRS scores will be compared between treatment groups.	Post-anesthesia care unit (PACU), 2 hours after surgery.
Postoperative pain intensity assessed with the Numerical Rating Scale (NRS)	Postoperative pain intensity will be assessed in adolescents using the Numerical Rating Scale (NRS). The NRS ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. Mean NRS scores will be compared between treatment groups.	Post-anesthesia care unit (PACU), 6 hours after surgery.
Postoperative pain intensity assessed with the Numerical Rating Scale (NRS)	Postoperative pain intensity will be assessed in adolescents using the Numerical Rating Scale (NRS). The NRS ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. Mean NRS scores will be compared between treatment groups.	Post-anesthesia care unit (PACU), 12 hours after surgery.
Postoperative pain intensity assessed with the Numerical Rating Scale (NRS)	Postoperative pain intensity will be assessed in adolescents using the Numerical Rating Scale (NRS). The NRS ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. Mean NRS scores will be compared between treatment groups.	Post-anesthesia care unit (PACU), 24 hours after surgery.
Postoperative pain intensity assessed with the Numerical Rating Scale (NRS)	Postoperative pain intensity will be assessed in adolescents using the Numerical Rating Scale (NRS). The NRS ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. Mean NRS scores will be compared between treatment groups.	Post-anesthesia care unit (PACU), 48 hours after surgery.
Adverse Events	Incidence of adverse events potentially related to the nerve block, including postoperative nausea and vomiting (PONV), hematoma, infection, or local anesthetic systemic toxicity (LAST).	Up to 30 days after surgery.
Incidence of perioperative hyperglycemia	Incidence of perioperative hyperglycemia, defined as blood glucose concentration >180 mg/dL (10 mmol/L), measured to evaluate potential systemic metabolic effects of dexamethasone or placebo administration. The proportion of patients who meet the hyperglycemia threshold will be compared between groups.	Up to 24 hours after surgery.

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Study Chair: Malgorzata Reysner, MD PhD, Poznan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease; Hand Injuries; Polycyclic Compounds; Inorganic Chemicals; Chlorine Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Sodium Compounds; Chlorides; Hydrochloric Acid; Dexamethasone; Sodium Chloride
• Other Study ID Numbers: 12_2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) that support the findings of this study will be made available to other researchers. Shared data will include baseline characteristics, anesthetic and surgical variables, primary and secondary outcome measures, adverse events, and follow-up assessments. No information that could identify participants will be included.
• IPD Sharing Time Frame: IPD will be made available beginning 12 months after publication of the primary study results and will remain available for 5 years thereafter.
• IPD Sharing Access Criteria: Data will be shared with qualified investigators for scientific or clinical research purposes upon reasonable request. Requests will be reviewed by the study investigators. A data sharing agreement may be required.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No