SII Levels Following PENG Block in Pediatric Hip Surgery

NCT07607535 | Not Yet Recruiting

• 1 other identifier: 5/2026
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Dysplasia

Outcome Measures

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.

  12 hours after surgery

Secondary Outcomes (18)

• Systemic Inflammation Response Index (SIRI)

  24 hours after surgery

• Systemic Inflammation Response Index (SIRI)

  48 hours after surgery

• Aggregate Index of Systemic Inflammation (AISI)

  12 hours after surgery

• Aggregate Index of Systemic Inflammation (AISI)

  24 hours after surgery

• Aggregate Index of Systemic Inflammation (AISI)

  48 hours after surgery

Study Arms (2)

Spinal Anesthesia Alone (Control)

SHAM COMPARATOR

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

Spinal Anesthesia + PENG Block

ACTIVE COMPARATOR

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

Interventions

Ropivacaine 0.2% Injectable Solution DRUG

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

Also known as: PENG block

Spinal Anesthesia + PENG Block

0.9%NaCl DRUG

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

Also known as: Sham Procedure

Spinal Anesthesia Alone (Control)

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan University of Medical Sciences

Poznan, 62-701, Poland

Location

MeSH Terms

Conditions

Hip Dislocation

Interventions

Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Małgorzata Reysner, MD PhD

  Poznań University of Medical Sciences

  STUDY CHAIR

Central Study Contacts

Małgorzata Reysner, MD PhD

CONTACT

+48 (61) 831-01-22; mreysner@ump.edu.pl

Tomasz Reysner, MD PhD

CONTACT

treysner@ump.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 26, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: May 26, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.

Locations

PL (1)