Skip to main content
OpenTrials
Completed

NCT Number: NCT06789367

The Effect of Dexamethasone Administration Route in PENG Block for Pediatric Hip Surgery

This study aims to assess the impact of the administration route of dexamethasone (intravenous vs. perineural) on postoperative pain, inflammatory response, and neuromonitoring parameters in pediatric patients undergoing hip surgery. The primary outcome is postoperative pain intensity measured using an age-appropriate pain scale at multiple time 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 hip surgery.

Completed

Looking for future studies?

Notify Me

Key information

Age range

3 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Poznan University of Medical Sciences

Poznan, 60-701, Poland

About this study

Pediatric hip 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. The pericapsular nerve group (PENG) block is a regional anesthesia technique that offers targeted analgesia for hip procedures while preserving motor function, making it particularly suitable for pediatric patients.

Dexamethasone is commonly used as an adjuvant in regional anesthesia to prolong analgesia and mitigate inflammation. However, the optimal administration route of dexamethasone in the context of PENG block for pediatric hip 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 PENG block. All patients will receive standardized general anesthesia and PENG 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. The study will also monitor neuromonitoring parameters during surgery to ensure patient safety and evaluate the influence of dexamethasone on neurological outcomes.

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 hip 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 4mg

Drug

PENG block with 0.5ml/kg 0.2% ropivacaine + 0,1mgkg perineural Dexamethasone

intravenous Dexamethsone 4mg

Drug

PENG block with 0,5ml/kg 0.2% ropivacaine + 0,1mg/kg intravenous Dexamethasone

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 on Pain and Inflammatory Response in PENG Block for Pediatric Hip Surgery

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2025
Registry last updated
Mar 16, 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.

Published trials that share one or more normalized conditions with this study.