An interventional study of Ropivacaine 0.2% Injectable Solution and 0.9%NaCl in Hip Dysplasia, sponsored by Poznan University of Medical Sciences. Recruiting at 1 site in Poland. Open to participants aged 3 Years to 8 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Poznan University of Medical Sciences · Not applicable, Interventional, and Treatment
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 the Systemic Inflammation Response Index (SIRI), a blood-based marker of inflammation, between the two groups at 12 hours after surgery.
Additional outcomes include other inflammatory markers, postoperative pain, opioid use, time to first rescue pain medication, and side effects.
Hip surgery in children is associated with a significant inflammatory and physiological stress response, which may contribute to postoperative pain, increased opioid requirements, and delayed recovery. Composite inflammatory indices derived from routine blood tests are increasingly used as accessible markers of systemic inflammation.
The Systemic Inflammation Response Index (SIRI), calculated as neutrophil count × monocyte count / lymphocyte count, is a blood-count-derived marker of systemic inflammation.
The pericapsular nerve group (PENG) block is a regional anesthesia technique used in hip surgery that provides effective analgesia with minimal motor impairment. Its potential effect on systemic inflammatory response remains insufficiently characterized.
The study is designed as a prospective, randomized, double-blind, single-center controlled trial with two parallel groups. Pediatric patients undergoing elective hip surgery will be allocated in a 1:1 ratio to receive spinal anesthesia alone or spinal anesthesia combined with ultrasound-guided PENG block. A sham procedure will be performed in the control group to maintain blinding.
Standardized perioperative management and postoperative analgesia will be applied in all participants.
The primary endpoint is SIRI at 12 hours after surgery, compared between the two study groups. Secondary endpoints include additional inflammatory indices, C-reactive protein levels, postoperative pain intensity, opioid consumption, time to first rescue analgesia, and incidence of adverse events.
Blood samples will be collected at predefined time points for the assessment of inflammatory markers.
107 studies on the registry are indexed under Hip Dislocation; 36 are open to participants now.
This study's planned enrollment of 100 is above 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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Participants will receive standardized spinal anesthesia according to institutional protocol. A sham procedure will be performed to maintain blinding. Postoperative analgesia will be standardized in all participants.
Drug: 0.9%NaCl
Participants will receive standardized spinal anesthesia combined with ultrasound-guided pericapsular nerve group (PENG) block using a local anesthetic (e.g., ropivacaine 0.2%). Postoperative analgesia will be standardized in all participants.
Drug: Ropivacaine 0.2% Injectable Solution
Ultrasound-guided regional anesthesia technique targeting the articular branches of the hip joint to provide postoperative analgesia.
Also known as: PENG block
Simulated procedure performed to maintain blinding without administration of local anesthetic.
Also known as: Sham Procedure
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 surgery
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 surgery
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 surgery
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 surgery
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 surgery
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: 48 hours after surgery
Platelet Mass Index (PMI)
Platelet Mass Index (PMI) reflects total circulating platelet mass and is calculated as: PMI = Platelet count × Mean Platelet Volume (MPV) Platelet count is expressed in ×10⁹/L and MPV in femtoliters (fL). PMI reflects platelet activation and thrombo-inflammatory potential, which may increase in response to surgical stress.
Time frame: 12 hours after surgery
Platelet Mass Index (PMI)
Platelet Mass Index (PMI) reflects total circulating platelet mass and is calculated as: PMI = Platelet count × Mean Platelet Volume (MPV) Platelet count is expressed in ×10⁹/L and MPV in femtoliters (fL). PMI reflects platelet activation and thrombo-inflammatory potential, which may increase in response to surgical stress.
Time frame: 24 hours after surgery
Platelet Mass Index (PMI)
Platelet Mass Index (PMI) reflects total circulating platelet mass and is calculated as: PMI = Platelet count × Mean Platelet Volume (MPV) Platelet count is expressed in ×10⁹/L and MPV in femtoliters (fL). PMI reflects platelet activation and thrombo-inflammatory potential, which may increase in response to surgical stress.
Time frame: 48 hours after surgery
C-reactive Protein (CRP) Concentration
C-reactive protein (CRP) is a laboratory marker of acute systemic inflammation measured in peripheral venous blood samples. CRP concentration is expressed in mg/L and determined using standard hospital laboratory methods. Higher CRP values indicate greater postoperative inflammatory response.
Time frame: 12 hours after surgery
C-reactive Protein (CRP) Concentration
C-reactive protein (CRP) is a laboratory marker of acute systemic inflammation measured in peripheral venous blood samples. CRP concentration is expressed in mg/L and determined using standard hospital laboratory methods. Higher CRP values indicate greater postoperative inflammatory response.
Time frame: 24 hours after surgery
C-reactive Protein (CRP) Concentration
C-reactive protein (CRP) is a laboratory marker of acute systemic inflammation measured in peripheral venous blood samples. CRP concentration is expressed in mg/L and determined using standard hospital laboratory methods. Higher CRP values indicate greater postoperative inflammatory response.
Time frame: 48 hours after surgery
Postoperative Pain Intensity
Postoperative pain intensity will be assessed using the FLACC scale (Face, Legs, Activity, Cry, Consolability), a validated observational pain scale for children, ranging from 0 to 10, where higher scores indicate greater pain intensity. Pain scores will be recorded at rest.
Time frame: 4 hours after surgery
Postoperative Pain Intensity
Postoperative pain intensity will be assessed using the FLACC scale (Face, Legs, Activity, Cry, Consolability), a validated observational pain scale for children, ranging from 0 to 10, where higher scores indicate greater pain intensity. Pain scores will be recorded at rest.
Time frame: 8 hours after surgery
Postoperative Pain Intensity
Postoperative pain intensity will be assessed using the FLACC scale (Face, Legs, Activity, Cry, Consolability), a validated observational pain scale for children, ranging from 0 to 10, where higher scores indicate greater pain intensity. Pain scores will be recorded at rest.
Time frame: 12 hours after surgery
Postoperative Pain Intensity
Postoperative pain intensity will be assessed using the FLACC scale (Face, Legs, Activity, Cry, Consolability), a validated observational pain scale for children, ranging from 0 to 10, where higher scores indicate greater pain intensity. Pain scores will be recorded at rest.
Time frame: 24 hours after surgery
Postoperative Pain Intensity
Postoperative pain intensity will be assessed using the FLACC scale (Face, Legs, Activity, Cry, Consolability), a validated observational pain scale for children, ranging from 0 to 10, where higher scores indicate greater pain intensity. Pain scores will be recorded at rest.
Time frame: 48 hours after surgery
Opioid Consumption
Total opioid consumption within the first 48 hours after surgery will be recorded. All administered opioids will be converted to intravenous morphine milligram equivalents (MME) for standardization. Higher cumulative MME indicates greater analgesic requirement.
Time frame: 48 hours after surgery
Time to First Rescue Analgesia
Time from completion of surgery to first administration of rescue opioid analgesia. Measured in minutes. Shorter time indicates earlier breakthrough pain.
Time frame: 48 hours after surgery
Plan to share: Yes — Individual participant data (IPD) underlying the results reported in this study, after de-identification, will be made available upon reasonable request. Shared data will include demographic information, intervention allocation, and outcome measures.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will be available beginning 6 months after publication of the primary results and will remain available for up to 5 years.
Access criteria: Access to data will be provided to researchers who submit a methodologically sound proposal. Requests will be reviewed by the principal investigator. Data will be shared after approval of a data access agreement.
No publications or documents are linked to this record.
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