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Completed

NCT Number: NCT07061678

The Effect of Dexamethasone Administration Route in Pediatric Brachial Plexus Block

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.

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Key information

Conditions

Arm

Age range

3 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Poznan University of Medical Sciences, Poznan, Poland

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About this study

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, double-blinded clinical trial will enroll pediatric patients undergoing elective hip surgery. Participants will be randomized into two groups: one group will receive intravenous dexamethasone, while the other will receive perineural dexamethasone administered as part of the infraclavicular brachial plexus block. All patients will receive standardized spinal anesthesia under mild sedation and infraclavicular brachial plexus block using a local anesthetic at a fixed concentration.

The primary outcome will be time to first request rescue analgesia. Secondary outcomes include the inflammatory response measured by NLR and PLR, postoperative pain intensity, assessed using an age-appropriate pain 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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

Primary outcomes

  1. Time to first rescue opioid analgesia

    Time frame: 48 hours after surgery

    Time to first rescue opioid analgesia

Secondary outcomes

  1. Total opioid consumption

    Time frame: 48 hours after surgery

    Total opioid consumption in milliequivalents of morphine

  2. NRS

    Time frame: 4 hours after surgery

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

  3. NRS

    Time frame: 8 hours after surgery

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

  4. NRS

    Time frame: 12 hours after surgery

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

  5. NRS

    Time frame: 24 hours after surgery

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

  6. NRS

    Time frame: 48 hours after surgery

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

  7. Nerve damage

    Time frame: 12 hours after surgery

    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

  8. Nerve damage

    Time frame: 24 hours after surgery

    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

  9. Nerve damage

    Time frame: 48 hours after surgery

    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

  10. NLR

    Time frame: 12 hours after surgery

    Neutrophile-to-lymphocyte ratio

  11. NLR

    Time frame: 24 hours after surgery

    Neutrophile-to-lymphocyte ratio

  12. NLR

    Time frame: 48 hours after surgery

    Neutrophile-to-lymphocyte ratio

  13. PLR

    Time frame: 12 hours after surgery

    Platelet-to-lymphocyte ratio

  14. PLR

    Time frame: 24 hours after surgery

    Platelet-to-lymphocyte ratio

  15. PLR

    Time frame: 48 hours after surgery

    Platelet-to-lymphocyte ratio

  16. glucose

    Time frame: 12 hours after surgery

    blood glucose levels

  17. glucose

    Time frame: 24 hours after surgery

    blood glucose levels

  18. glucose

    Time frame: 48 hours after surgery

    blood glucose levels

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 11, 2025
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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