The Effect of Dexamethasone Administration Route in Pediatric Brachial Plexus Block

NCT07061678 | Recruiting Phase 4

• 1 other identifier: 5/2025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Arm

Outcome Measures

Primary Outcomes (1)

• Time to first rescue opioid analgesia

  Time to first rescue opioid analgesia

  48 hours after surgery

Secondary Outcomes (18)

• Total opioid consumption

  48 hours after surgery

• NRS

  4 hours after surgery

• NRS

  8 hours after surgery

• NRS

  12 hours after surgery

• NRS

  24 hours after surgery

Study Arms (3)

perinerual dexamethasone

ACTIVE COMPARATOR

infraclavicular brachial plexus block + perineural dexamethasone

Drug: perineural dexamethasone

intravenous dexamethasone

ACTIVE COMPARATOR

infraclavicular brachial plexus block + intravenous dexamethasone

Drug: intravenous dexamethasone

0.2ml/kg 0.2% ropivacaine

PLACEBO COMPARATOR

infraclavicular brachial plexus block

Drug: 0.2ml/kg 0.2% ropivacaine

Interventions

perineural dexamethasone DRUG

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

perinerual dexamethasone

intravenous dexamethasone DRUG

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

intravenous dexamethasone

0.2ml/kg 0.2% ropivacaine DRUG

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

0.2ml/kg 0.2% ropivacaine

Eligibility Criteria

• Age: 3 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (2)

Poznan University of Medical Sciences

Poznan, 61-701, Poland

RECRUITING

Poznan University of Medical Sciences

Poznan, Poland

NOT YET RECRUITING

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Malgorzata Reysner, M.D. Ph.D.

  Poznan University of Medicl Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Malgorzata Reysner, M.D. Ph.D.

CONTACT

+48 61 873 83 03; mreysner@ump.edu.pl

Study Design

• Study Type: interventional
• Phase: phase 4
• 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: June 8, 2025
• First Posted: July 11, 2025
• Study Start: October 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: February 28, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-09

Locations

PL (2)