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

Phase 4

Recruiting

• Conditions: Hip Dysplasia; Hip Disease
• Interventions: Drug: perineural Dexamethasone 4mg; Drug: intravenous Dexamethsone 4mg

• Registration Number: NCT06789367
• Lead Sponsor: Poznan University of Medical Sciences

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-17
• Study First Submitted QC: 2025-01-17
• Study First Posted: 2025-01-23
• Study Start: 2025-02-01
• Last Update Submitted: 2025-07-08
• Last Update Posted: 2025-07-11
• Primary Completion: 2026-02-28
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
perinerual dexamethasone	perineural Dexamethasone 4mg	PENG block + perineural dexamethasone
intravenous dexamethasone	intravenous Dexamethsone 4mg	PENG block + intravenous dexamethasone

Primary Outcome Measures

Name	Time	Method
Time to first rescue opioid analgesia	48 hours after surgery	Time to first rescue opioid analgesia

Secondary Outcome Measures

Name	Time	Method
NLR	48 hours after surgery	Neutrophile-to-lymphocyte ratio
PLR	48 hours after surgery	Platelet-to-lymphocyte ratio
glucose	48 hours after surgery	blood glucose levels
Total opioid consumption	48 hours after surgery	Total opioid consumption in milliequivalents of morphine
Nerve damage	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
NRS	48 hours after surgery	The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."

Trial Locations

Locations (1)

Poznan University of Medical Sciences; 🇵🇱 Poznan, Poland