SII Levels Following PENG Block in Pediatric Hip Surgery
ConditionHip Dysplasia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-8
SponsorPoznan University of Medical Sciences
About this trial
This study is a prospective, randomized, double-blind clinical trial. Its aim is to evaluate whether adding a pericapsular nerve group (PENG) block to spinal anesthesia can reduce the inflammatory response after hip surgery in children.
Hip surgery in children can cause a strong stress and inflammatory reaction, which may affect pain after surgery, the need for opioid medications, and recovery.
Children aged 3 to 8 years will be randomly assigned to one of two groups: spinal anesthesia alone or spinal anesthesia combined with a PENG block. The main goal is to compare changes in the Systemic Immune-Inflammation Index (SII), a blood-based marker of inflammation, measured before surgery and 24 hours after surgery.
Additional outcomes include other inflammatory markers, postoperative pain, opioid use, time to first rescue pain medication, and side effects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 3-8 years
Scheduled for elective unilateral hip surgery
American Society of Anesthesiologists (ASA) physical status I-III
Written informed consent from the parent or legal guardian
Disqualifiers
Contraindications to spinal anesthesia or PENG block
Infection at the planned needle insertion site
Coagulation disorders
Chronic immunosuppressive therapy or chronic steroid use
Trial design
Design model
Parallel
Treatments tested in this trial
Ropivacaine 0.2% Injectable Solution
DrugUltrasound-guided regional anesthesia technique targeting the articular branches of the hip joint to provide postoperative analgesia.
0.9%NaCl
DrugSimulated procedure performed to maintain blinding without administration of local anesthetic.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Spinal Anesthesia Alone (Control)Sham comparator 1 intervention
Group B: Spinal Anesthesia + PENG BlockActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Systemic Inflammation Response Index (SIRI)
Systemic Inflammation Response Index (SIRI) is used as a composite marker of systemic inflammatory activation. It is calculated from peripheral venous blood samples using the formula: SIRI = (Neutrophil count × Monocyte count) / Lymphocyte count All parameters are obtained from routine complete blood count (CBC) analysis and expressed in ×10⁹/L. SIRI reflects the interaction between innate immune activation (neutrophils and monocytes) and adaptive immune suppression (lymphocytes). Higher SIRI values indicate greater systemic inflammatory response.
Time frame
12 hours after surgerySecondary outcomes
1
Systemic Inflammation Response Index (SIRI)
Systemic Inflammation Response Index (SIRI) is used as a composite marker of systemic inflammatory activation. It is calculated from peripheral venous blood samples using the formula: SIRI = (Neutrophil count × Monocyte count) / Lymphocyte count All parameters are obtained from routine complete blood count (CBC) analysis and expressed in ×10⁹/L. SIRI reflects the interaction between innate immune activation (neutrophils and monocytes) and adaptive immune suppression (lymphocytes). Higher SIRI values indicate greater systemic inflammatory response.
Time frame
24 hours after surgery2
Systemic Inflammation Response Index (SIRI)
Systemic Inflammation Response Index (SIRI) is used as a composite marker of systemic inflammatory activation. It is calculated from peripheral venous blood samples using the formula: SIRI = (Neutrophil count × Monocyte count) / Lymphocyte count All parameters are obtained from routine complete blood count (CBC) analysis and expressed in ×10⁹/L. SIRI reflects the interaction between innate immune activation (neutrophils and monocytes) and adaptive immune suppression (lymphocytes). Higher SIRI values indicate greater systemic inflammatory response.
Time frame
48 hours after surgery3
Aggregate Index of Systemic Inflammation (AISI)
Aggregate Index of Systemic Inflammation (AISI) is calculated as: AISI = (Neutrophil count × Monocyte count × Platelet count) / Lymphocyte count All values are obtained from routine CBC and expressed in ×10⁹/L. AISI integrates neutrophils, monocytes, platelets, and lymphocytes, providing a broader assessment of systemic inflammatory and immune response compared to single ratios.
Time frame
12 hours after surgery4
Aggregate Index of Systemic Inflammation (AISI)
Aggregate Index of Systemic Inflammation (AISI) is calculated as: AISI = (Neutrophil count × Monocyte count × Platelet count) / Lymphocyte count All values are obtained from routine CBC and expressed in ×10⁹/L. AISI integrates neutrophils, monocytes, platelets, and lymphocytes, providing a broader assessment of systemic inflammatory and immune response compared to single ratios.
Time frame
24 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: