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

NCT07474909 | Recruiting

• 1 other identifier: 12_2025
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand Injuries and Disorders; Wrist Sprain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Time to First rescue analgesia

  Within 0-48 hours after surgery.

• Total Opioid Consumption

  0-48 hours after surgery.

• Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale

  Post-anesthesia care unit (PACU), 2 hours after surgery.

• Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale

  Post-anesthesia care unit (PACU), 6 hours after surgery.

• Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale

  Post-anesthesia care unit (PACU), 12 hours after surgery.

Study Arms (3)

Intravenous Dexamethasone + Perineural Placebo

ACTIVE COMPARATOR

Brachial plexus block with ropivacaine + dexamethasone IV 0.1 mg/kg (max 8 mg) and perineural 0.9% NaCl.

Drug: iv dexamethasone

Perineural Dexamethasone + Intravenous Placebo

ACTIVE COMPARATOR

Brachial plexus block with ropivacaine + dexamethasone perineurally 0.1 mg/kg (max 4 mg) and IV 0.9% NaCl.

Drug: pn dexamethasone

Placebo (IV + Perineural)

ACTIVE COMPARATOR

Brachial plexus block with ropivacaine + 0.9% NaCl both IV and perineurally.

Drug: 0.9%NaCl

Interventions

iv dexamethasone DRUG

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.

Intravenous Dexamethasone + Perineural Placebo

pn dexamethasone DRUG

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.

Perineural Dexamethasone + Intravenous Placebo

0.9%NaCl DRUG

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.

Placebo (IV + Perineural)

Eligibility Criteria

• Age: 3 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan University of Medical Sciences

Poznan, 62-701, Poland

RECRUITING

MeSH Terms

Conditions

Hand Injuries; Disease

Interventions

Dexamethasone; Sodium Chloride

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Malgorzata Reysner, MD PhD

  Poznan University of Medical Sciences

  STUDY CHAIR

Central Study Contacts

Malgorzata Reysenr, MD PhD

CONTACT

48618738313; mreysner@ump.edu.pl

Malgorzata Reysner, MD PhD

CONTACT

48618738313; mreysner@ump.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: March 16, 2026
• Study Start: December 10, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: May 22, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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.

Locations

PL (1)