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

The Effect of Dexamethasone Administration Route on Pain and Inflammatory Response 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.

Study Overview

• Status: Completed
• Conditions: Hip Dysplasia; Hip Disease
• Intervention / Treatment: Drug: perineural Dexamethasone 4mg; Drug: intravenous Dexamethsone 4mg

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Poznan, Poland, 60-701
    • Poznan University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: perinerual dexamethasone; PENG block + perineural dexamethasone	Drug: perineural Dexamethasone 4mg; PENG block with 0.5ml/kg 0.2% ropivacaine + 0,1mgkg perineural Dexamethasone
Active Comparator: intravenous dexamethasone; PENG block + intravenous dexamethasone	Drug: intravenous Dexamethsone 4mg; PENG block with 0,5ml/kg 0.2% ropivacaine + 0,1mg/kg intravenous Dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first rescue opioid analgesia	Time to first rescue opioid analgesia	48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PLR	Platelet-to-lymphocyte ratio	48 hours after surgery
PLR	Platelet-to-lymphocyte ratio	12 hours after surgery
PLR	Platelet-to-lymphocyte ratio	24 hours after surgery
glucose	blood glucose levels	24 hours after surgery
glucose	blood glucose levels	48 hours after surgery
Nerve damage	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	12 hours after surgery
Nerve damage	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	24 hours after surgery
Nerve damage	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	48 hours after surgery
glucose	blood glucose levels	12 hours after surgery
NLR	Neutrophile-to-lymphocyte ratio	24 hours after surgery
NLR	Neutrophile-to-lymphocyte ratio	48 hours after surgery
Total opioid consumption	Total opioid consumption in milliequivalents of morphine	48 hours after surgery
NRS	The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."	4 hours after surgery
NRS	The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."	8 hours after surgery
NRS	The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."	12 hours after surgery
NRS	The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."	24 hours after surgery
NRS	The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."	48 hours after surgery
NLR	Neutrophile-to-lymphocyte ratio	12 hours after surgery

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Study Chair: Malgorzata Reysner, M.D. Ph.D., Poznan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Actual): February 14, 2026
• Study Completion (Actual): March 3, 2026

Study Registration Dates

• First Submitted: January 17, 2025
• First Submitted That Met QC Criteria: January 17, 2025
• First Posted (Actual): January 23, 2025

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: adjuvant; dexamethasone; PENG block; pericapsular nerve group block
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Wounds and Injuries; Joint Diseases; Hip Injuries; Joint Dislocations; Hip Dislocation; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: 3/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No