A Phase 4 interventional study of perineural Dexamethasone 4mg and intravenous Dexamethsone 4mg in Hip Dysplasia and Hip Disease, sponsored by Poznan University of Medical Sciences. Completed at 1 site in Poland. Open to participants aged 3 Months to 6 Years. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Poznan University of Medical Sciences · Phase 4, Interventional, and Treatment
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.
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.
107 studies on the registry are indexed under Hip Dislocation; 36 are open to participants now.
This study's enrollment of 60 is below the median of 86 across 64 interventional studies indexed under Hip Dislocation.
Browse Hip Dislocation studies →Poznan University of Medical Sciences is the lead sponsor of 151 studies on the registry; 41 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PENG block + perineural dexamethasone
Drug: perineural Dexamethasone 4mg
PENG block + intravenous dexamethasone
Drug: intravenous Dexamethsone 4mg
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 to first rescue opioid analgesia
Time to first rescue opioid analgesia
Time frame: 48 hours after surgery
Total opioid consumption
Total opioid consumption in milliequivalents of morphine
Time frame: 48 hours after surgery
NRS
The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
Time frame: 4 hours after surgery
NRS
The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
Time frame: 8 hours after surgery
NRS
The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
Time frame: 12 hours after surgery
NRS
The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
Time frame: 24 hours after surgery
NRS
The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 48 hours after surgery
NLR
Neutrophile-to-lymphocyte ratio
Time frame: 12 hours after surgery
NLR
Neutrophile-to-lymphocyte ratio
Time frame: 24 hours after surgery
NLR
Neutrophile-to-lymphocyte ratio
Time frame: 48 hours after surgery
PLR
Platelet-to-lymphocyte ratio
Time frame: 12 hours after surgery
PLR
Platelet-to-lymphocyte ratio
Time frame: 24 hours after surgery
PLR
Platelet-to-lymphocyte ratio
Time frame: 48 hours after surgery
glucose
blood glucose levels
Time frame: 12 hours after surgery
glucose
blood glucose levels
Time frame: 24 hours after surgery
glucose
blood glucose levels
Time frame: 48 hours after surgery
Plan to share: Yes
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Ran from Feb 2025 to primary completion in Feb 2026, 12 months.
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