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

May 20, 2026 updated by: Poznan University of Medical Sciences

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Poland
      • Poznan, Poland, 62-701
        • Recruiting
        • Poznan University of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Persistent Neurological Deficit
Time Frame: up to 12 months
Incidence of sensory or motor neurological deficit attributed to the block that persists ≥3 months postoperatively.
up to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to First rescue analgesia
Time Frame: Within 0-48 hours after surgery.
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
Time Frame: 0-48 hours after surgery.
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
Time Frame: Post-anesthesia care unit (PACU), 2 hours after surgery.

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

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

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
Time Frame: Post-anesthesia care unit (PACU), 24 hours after surgery.

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
Time Frame: Post-anesthesia care unit (PACU), 48 hours after surgery.

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

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

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

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)
Time Frame: Post-anesthesia care unit (PACU), 24 hours after surgery.

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)
Time Frame: Post-anesthesia care unit (PACU), 48 hours after surgery.

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
Time Frame: Up to 30 days after surgery.
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
Time Frame: Up to 24 hours after surgery.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Poznan University of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Malgorzata Reysner, MD PhD, Poznan University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hand Injuries and Disorders

Clinical Trials on iv dexamethasone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings