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NCT Number: NCT07607535

SII Levels Following PENG Block in Pediatric Hip Surgery

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.

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Key information

Conditions

Hip Dysplasia Hip Dislocation Hip Injuries Joint Diseases Joint Dislocations Musculoskeletal Diseases Wounds and Injuries

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Poznan University of Medical Sciences

Poznan, 62-701, Poland

About this study

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 Immune-Inflammation Index (SII), calculated as platelet count × neutrophil count / lymphocyte count, reflects the balance between inflammatory and immune responses and has been proposed as a sensitive indicator of surgical stress.

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 the change in SII between the preoperative baseline and 24 hours after surgery. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Contraindications to spinal anesthesia or PENG block
  • Infection at the planned needle insertion site
  • Coagulation disorders
  • Chronic immunosuppressive therapy or chronic steroid use
  • Active infection or inflammatory disease
  • Ongoing oncological treatment
  • Known allergy to local anesthetics or study-related medications
  • Conversion to general anesthesia
  • Refusal to participate

Treatment and study plan

Ropivacaine 0.2% Injectable Solution

Drug

Ultrasound-guided regional anesthesia technique targeting the articular branches of the hip joint to provide postoperative analgesia.

Other names: PENG block

0.9%NaCl

Drug

Simulated procedure performed to maintain blinding without administration of local anesthetic.

Other names: Sham Procedure

Primary outcomes

  1. Systemic Inflammation Response Index (SIRI)

    Time frame: 12 hours after surgery

    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.

Secondary outcomes

  1. Systemic Inflammation Response Index (SIRI)

    Time frame: 24 hours after surgery

    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.

  2. Systemic Inflammation Response Index (SIRI)

    Time frame: 48 hours after surgery

    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.

  3. Aggregate Index of Systemic Inflammation (AISI)

    Time frame: 12 hours after surgery

    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.

  4. Aggregate Index of Systemic Inflammation (AISI)

    Time frame: 24 hours after surgery

    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.

  5. Aggregate Index of Systemic Inflammation (AISI)

    Time frame: 48 hours after surgery

    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.

  6. Platelet Mass Index (PMI)

    Time frame: 12 hours after surgery

    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.

  7. Platelet Mass Index (PMI)

    Time frame: 24 hours after surgery

    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.

  8. Platelet Mass Index (PMI)

    Time frame: 48 hours after surgery

    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.

  9. C-reactive Protein (CRP) Concentration

    Time frame: 12 hours after surgery

    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.

  10. C-reactive Protein (CRP) Concentration

    Time frame: 24 hours after surgery

    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.

  11. C-reactive Protein (CRP) Concentration

    Time frame: 48 hours after surgery

    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.

  12. Postoperative Pain Intensity

    Time frame: 4 hours after surgery

    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.

  13. Postoperative Pain Intensity

    Time frame: 8 hours after surgery

    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.

  14. Postoperative Pain Intensity

    Time frame: 12 hours after surgery

    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.

  15. Postoperative Pain Intensity

    Time frame: 24 hours after surgery

    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.

  16. Postoperative Pain Intensity

    Time frame: 48 hours after surgery

    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.

  17. Opioid Consumption

    Time frame: 48 hours after surgery

    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.

  18. Time to First Rescue Analgesia

    Time frame: 48 hours after surgery

    Time from completion of surgery to first administration of rescue opioid analgesia.

    Measured in minutes. Shorter time indicates earlier breakthrough pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Małgorzata Reysner, MD PhD

CONTACT

[email protected]

+48 (61) 831-01-22

Tomasz Reysner, MD PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study title

Pericapsular Nerve Group Block Mitigates Surgical Stress and Enhances Analgesia in Pediatric Hip Surgery: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 26, 2026
Registry last updated
May 26, 2026

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.

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