Poznan University of Medical Sciences
Poznan, 60-701, Poland
NCT Number: NCT06789367
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.
Looking for future studies?
Notify Me3 month–6 year
All sexes
Interventional
Phase 4
Poznan, 60-701, Poland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PENG block with 0.5ml/kg 0.2% ropivacaine + 0,1mgkg perineural Dexamethasone
PENG block with 0,5ml/kg 0.2% ropivacaine + 0,1mg/kg intravenous Dexamethasone
Time frame: 48 hours after surgery
Time to first rescue opioid analgesia
Time frame: 48 hours after surgery
Total opioid consumption in milliequivalents of morphine
Time frame: 4 hours after surgery
The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
Time frame: 8 hours after surgery
The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
Time frame: 12 hours after surgery
The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
Time frame: 24 hours after surgery
The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
Time frame: 48 hours after surgery
The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
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
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
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
Time frame: 12 hours after surgery
Neutrophile-to-lymphocyte ratio
Time frame: 24 hours after surgery
Neutrophile-to-lymphocyte ratio
Time frame: 48 hours after surgery
Neutrophile-to-lymphocyte ratio
Time frame: 12 hours after surgery
Platelet-to-lymphocyte ratio
Time frame: 24 hours after surgery
Platelet-to-lymphocyte ratio
Time frame: 48 hours after surgery
Platelet-to-lymphocyte ratio
Time frame: 12 hours after surgery
blood glucose levels
Time frame: 24 hours after surgery
blood glucose levels
Time frame: 48 hours after surgery
blood glucose levels
Poznan University of Medical Sciences
Other
The Effect of Dexamethasone Administration Route on Pain and Inflammatory Response in PENG Block for Pediatric Hip Surgery
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.
NCT06087549
Femoral Fractures, Fractures, Bone
Poznan, Wielkopolska, Poland
View Trial DetailsNCT05361980
Congenital Abnormalities, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Vancouver, British Columbia, Canada
View Trial DetailsNCT07023094
Hip Arthropathy, Hip Disease
Poznan, Poland
View Trial DetailsNCT03109444
Hip Dislocation, Hip Dysplasia
Fresno, California, United States
View Trial Details