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AzTrials

ArmPhase 4NCT07061678

The Effect of Dexamethasone Administration Route in Pediatric Brachial Plexus Block

A Phase 4 study testing perineural dexamethasone, intravenous dexamethasone and 0.2ml/kg 0.2% ropivacaine in people with Arm, run by Poznan University of Medical Sciences at 2 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to assess the impact of the administration route of dexamethasone (intravenous vs. perineural) on postoperative pain and inflammatory response in pediatric patients undergoing hand/wrist surgery. The primary outcome is time from the end of surgery to first rescue opioid analgesia within 48 hours. Read more about this study

Who is it for?
Ages 3 months to 6 years
Conditions the study is for
Arm
What is being tested?
perineural dexamethasone, intravenous dexamethasone and 0.2ml/kg 0.2% ropivacaine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
2 sitesPoland
Study dates
1 Oct 2025to 15 Jun 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 months to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • children scheduled for arm/wrist/hand surgery
  • body weight > 5kg

Who cannot join

  • infection at the site of the regional block,
  • coagulation disorders,
  • immunodeficiency,
  • American Society of Anesthesiologists (ASA) physical status of IV or higher,
  • history of regular steroid medication.

Trial locations and contacts

2 sites in 1 country.

Poland2 sites

  • Poznan University of Medical Sciences

    Poznan, 61-701

  • Poznan University of Medical Sciences

    Poznan

Other trials in Poland

About this study

Official title: The Effect of Dexamethasone Administration Route in Infraclavicular Brachial Plexus Block for Pediatric Arm and/or Hand Surgery

This study aims to assess the impact of the administration route of dexamethasone (intravenous vs. perineural) on postoperative pain and inflammatory response in pediatric patients undergoing hand/wrist surgery. The primary outcome is time from the end of surgery to first rescue opioid analgesia within 48 hours. Secondary outcomes include inflammatory markers such as neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), opioid consumption, postoperative pain intensity assessed using the FLACC scale, blood glucose levels, and neurological status. This randomized, quadruple -blinded study seeks to improve pain management strategies and optimize anesthesia protocols in pediatric arm surgery.

Read the detailed description

Pediatric arm surgery is a complex procedure that can result in significant postoperative pain and an inflammatory response. Effective pain management is critical in this population to promote early mobilization, reduce opioid consumption, and minimize adverse outcomes.

Dexamethasone is an adjuvant in regional anesthesia that prolongs analgesia and mitigates inflammation. However, the optimal administration route of dexamethasone in infraclavicular brachial plexus block for pediatric arm surgery remains unclear. This study is designed to compare the efficacy of intravenous versus perineural dexamethasone in prolonging postoperative analgesia and reducing inflammatory responses.

This prospective, randomized, quadruple-blinded clinical trial will enroll pediatric patients undergoing elective hand/wrist surgery. Participants will be randomized into three groups: perineural dexamethasone, intravenous dexamethasone, or saline placebo. All groups will receive an infraclavicular brachial plexus block with ropivacaine. All patients will receive standardized general anesthesia and an infraclavicular brachial plexus block using a local anesthetic at a fixed concentration.

The primary outcome will be time from the end of surgery to first administration of rescue opioid analgesia within 48 hours. Secondary outcomes include the inflammatory response measured by NLR and PLR, postoperative pain intensity, assessed using the FLACC scale at predefined time intervals, total opioid consumption, and blood glucose levels.

Safety will be closely monitored throughout the study, with particular attention to potential complications such as local anesthetic systemic toxicity (LAST) or dexamethasone-related adverse events.

Conditions
Arm
Being tested
perineural dexamethasone, intravenous dexamethasone, 0.2ml/kg 0.2% ropivacaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • perineural dexamethasoneDrug

    infraclavicular brachial plexus block with 0.2ml/kg 0.2% ropivacaine with 0.1mg/kg perineural dexamethasone

  • intravenous dexamethasoneDrug

    infraclavicular brachial plexus block with 0.2ml/kg 0.2% ropivacaine with 0.1mg/kg intravenous dexamethasone

  • 0.2ml/kg 0.2% ropivacaineDrug

    infraclavicular brachial plexus block with 0.2ml/kg 0.2% ropivacaine

Study groups in NCT07061678
Study groupRoleWhat they receive
perinerual dexamethasoneActive comparatorinfraclavicular brachial plexus block + perineural dexamethasone
Receives: Drug: perineural dexamethasone
intravenous dexamethasoneActive comparatorinfraclavicular brachial plexus block + intravenous dexamethasone
Receives: Drug: intravenous dexamethasone
0.2ml/kg 0.2% ropivacainePlacebo comparatorinfraclavicular brachial plexus block
Receives: Drug: 0.2ml/kg 0.2% ropivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first rescue opioid analgesia

    Time to first rescue opioid analgesia

    Measured: 48 hours after surgery

Secondary outcomes (18)

  1. Total opioid consumption

    Total opioid consumption in milliequivalents of morphine

    Measured: 48 hours after surgery

  2. Pain scores - FLACC (Face, Legs, Activity, Cry, Consolability)

    The pain FLACC (Face, Legs, Activity, Cry, Consolability) score with zero meaning "no pain" and 10 meaning "the worst pain imaginable."

    Measured: 4 hours after surgery

  3. Pain scores - FLACC (Face, Legs, Activity, Cry, Consolability)

    The pain FLACC (Face, Legs, Activity, Cry, Consolability) score with zero meaning "no pain" and 10 meaning "the worst pain imaginable."

    Measured: 8 hours after surgery

  4. Pain scores - FLACC (Face, Legs, Activity, Cry, Consolability)

    The pain FLACC (Face, Legs, Activity, Cry, Consolability) score with zero meaning "no pain" and 10 meaning "the worst pain imaginable."

    Measured: 12 hours after surgery

  5. Pain scores - FLACC (Face, Legs, Activity, Cry, Consolability)

    The pain FLACC (Face, Legs, Activity, Cry, Consolability) score with zero meaning "no pain" and 10 meaning "the worst pain imaginable."

    Measured: 24 hours after surgery

  6. Pain scores - FLACC (Face, Legs, Activity, Cry, Consolability)

    The pain FLACC (Face, Legs, Activity, Cry, Consolability) score with zero meaning "no pain" and 10 meaning "the worst pain imaginable."

    Measured: 48 hours after surgery

  7. Nerve damage

    Nerve damage assesent will be performed using scale: N0- no nerve damage; N1- minor - sensory paresthesia; N2- majorcomplete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome

    Measured: 12 hours after surgery

  8. Nerve damage

    Nerve damage assesent will be performed using scale: N0- no nerve damage; N1- minor - sensory paresthesia; N2- majorcomplete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome

    Measured: 24 hours after surgery

  9. Nerve damage

    Nerve damage assesent will be performed using scale: N0- no nerve damage; N1- minor - sensory paresthesia; N2- majorcomplete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome

    Measured: 48 hours after surgery

  10. NLR

    Neutrophile-to-lymphocyte ratio

    Measured: 12 hours after surgery

  11. NLR

    Neutrophile-to-lymphocyte ratio

    Measured: 24 hours after surgery

  12. NLR

    Neutrophile-to-lymphocyte ratio

    Measured: 48 hours after surgery

  13. PLR

    Platelet-to-lymphocyte ratio

    Measured: 12 hours after surgery

  14. PLR

    Platelet-to-lymphocyte ratio

    Measured: 24 hours after surgery

  15. PLR

    Platelet-to-lymphocyte ratio

    Measured: 48 hours after surgery

  16. glucose

    blood glucose levels

    Measured: 12 hours after surgery

  17. glucose

    blood glucose levels

    Measured: 24 hours after surgery

  18. glucose

    blood glucose levels

    Measured: 48 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2025
  2. Study start1 Oct 2025
  3. Primary completion30 May 2026
  4. Study completion15 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07061678
Sponsor's protocol ID
5/2025
Status last verified
Nov 2026
First submitted
8 Jun 2025
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing perineural dexamethasone, intravenous dexamethasone and 0.2ml/kg 0.2% ropivacaine in people with Arm, run by Poznan University of Medical Sciences at 2 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first rescue opioid analgesia (time frame: 48 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07061678.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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