Clinical trial NCT06789367: The Effect of Dexamethasone Administration Route in PENG Block for Pediatric Hip Surgery
Official title: The Effect of Dexamethasone Administration Route on Pain and Inflammatory Response in PENG Block for Pediatric Hip Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Hip Dysplasia
Hip Disease
Keywords: pericapsular nerve group block
PENG block
dexamethasone
adjuvant
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to first rescue opioid analgesia
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Total opioid consumption
timeFrame: 48 hours after surgery
measure: NRS
timeFrame: 4 hours after surgery
measure: NRS
timeFrame: 8 hours after surgery
measure: NRS
timeFrame: 12 hours after surgery
measure: NRS
timeFrame: 24 hours after surgery
measure: NRS
timeFrame: 48 hours after surgery
measure: Nerve damage
timeFrame: 12 hours after surgery
measure: Nerve damage
timeFrame: 24 hours after surgery
measure: Nerve damage
timeFrame: 48 hours after surgery
measure: NLR
timeFrame: 12 hours after surgery
measure: NLR
timeFrame: 24 hours after surgery
measure: NLR
timeFrame: 48 hours after surgery
measure: PLR
timeFrame: 12 hours after surgery
measure: PLR
timeFrame: 24 hours after surgery
measure: PLR
timeFrame: 48 hours after surgery
measure: glucose
timeFrame: 12 hours after surgery
measure: glucose
timeFrame: 24 hours after surgery
measure: glucose
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Poznan University of Medical Sciences
Study officials:
affiliation: Poznań University of Medical Sciences
name: Malgorzata Reysner, M.D. Ph.D.
role: STUDY_CHAIR
References: