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The Effect of Dexamethasone Administration Route in Pediatric Brachial Plexus Block

ConditionArm
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age3-6
SponsorPoznan University of Medical Sciences

About this trial

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 hip surgery. The primary outcome is postoperative pain intensity measured using an age-appropriate scale at multiple intervals. Secondary outcomes include inflammatory markers such as neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), opioid consumption, time-to-first rescue analgesia, and overall patient recovery. This randomized, double-blinded study seeks to improve pain management strategies and optimize anesthesia protocols in pediatric arm surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

children scheduled for arm/wrist/hand surgery

body weight > 5kg

Disqualifiers

infection at the site of the regional block,

coagulation disorders,

immunodeficiency,

American Society of Anesthesiologists (ASA) physical status of IV or higher,

Trial design

Design model

Parallel

Treatments tested in this trial

  • perineural dexamethasone

    Drug

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

  • intravenous dexamethasone

    Drug

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

  • 0.2ml/kg 0.2% ropivacaine

    Drug

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

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: perinerual dexamethasoneActive comparator 1 intervention
Group B: intravenous dexamethasoneActive comparator 1 intervention
Group C: 0.2ml/kg 0.2% ropivacainePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to first rescue opioid analgesia

Time to first rescue opioid analgesia

Time frame
48 hours after surgery

Secondary outcomes

1

Total opioid consumption

Total opioid consumption in milliequivalents of morphine

Time frame
48 hours after surgery
2

NRS

The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."

Time frame
4 hours after surgery
3

NRS

The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."

Time frame
8 hours after surgery
4

NRS

The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."

Time frame
12 hours after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Poznan University of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov
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