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

NCT06789367 | Completed Phase 4

• 1 other identifier: 3/2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Dysplasia; Hip Disease

Keywords

pericapsular nerve group block; PENG block; dexamethasone; adjuvant

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 (2)

perinerual dexamethasone

ACTIVE COMPARATOR

PENG block + perineural dexamethasone

Drug: perineural Dexamethasone 4mg

intravenous dexamethasone

ACTIVE COMPARATOR

PENG block + intravenous dexamethasone

Drug: intravenous Dexamethsone 4mg

Interventions

intravenous Dexamethsone 4mg DRUG

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

intravenous dexamethasone

perineural Dexamethasone 4mg DRUG

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

perinerual dexamethasone

Eligibility Criteria

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

You may qualify if:

• children scheduled for hip 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 (1)

Poznan University of Medical Sciences

Poznan, 60-701, Poland

Location

MeSH Terms

Conditions

Hip Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries

Study Officials

• Malgorzata Reysner, M.D. Ph.D.

  Poznań University of Medical Sciences

  STUDY CHAIR

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: January 17, 2025
• First Posted: January 23, 2025
• Study Start: February 1, 2025
• Primary Completion: February 14, 2026
• Study Completion: March 3, 2026
• Last Updated: March 16, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

PL (1)