Hip DysplasiaNCT07607535
SIRI Levels Following PENG Block in Pediatric Hip Surgery
A study testing Ropivacaine 0.2% Injectable Solution and 0.9%NaCl in people with Hip Dysplasia, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Hip Dysplasia
- What is being tested?
- Ropivacaine 0.2% Injectable Solution and 0.9%NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Known allergy to local anesthetics or study-related medications
- Conversion to general anesthesia
- Refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tomasz Reysner, MD PhD contact
Poland1 site, 1 recruiting
- Recruiting
Poznan University of Medical Sciences
Skórzewo, Poznań, 61-701
Malgorzata Reysner, M.D. Ph.D., 608762068, mreysenr@ump.edu.pl
Małgorzata Reysner, M.D. Ph.D., mreysner@ump.edu.pl
About this study
Official title: Pericapsular Nerve Group Block Mitigates Surgical Stress and Enhances Analgesia in Pediatric Hip Surgery: A Randomized Controlled 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Hip Dysplasia
- Being tested
- Ropivacaine 0.2% Injectable Solution, 0.9%NaCl
- Medical subject headings
- Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.2% Injectable SolutionDrug
Also called PENG block
Ultrasound-guided regional anesthesia technique targeting the articular branches of the hip joint to provide postoperative analgesia.
0.9%NaClDrug
Also called Sham Procedure
Simulated procedure performed to maintain blinding without administration of local anesthetic.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Ropivacaine 0.2% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 hours after surgery
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 Jun 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Małgorzata Reysner, MD PhD, Study chair, Poznań University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607535
- Sponsor's protocol ID
- 5/2026
- Status last verified
- Nov 2026
- First submitted
- 6 May 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pericapsular Nerve Group Block Mitigates Surgical Stress and Enhances Analgesia in Pediatric Hip Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07607535
- Acronym / sponsor ID
- 5/2026
- Conditions
- Hip Dysplasia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Anesthesia Alone (Control) | Sham comparator | Drug: 0.9%NaClParticipants 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. |
| Spinal Anesthesia + PENG Block | Active comparator | Drug: Ropivacaine 0.2% Injectable SolutionParticipants 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. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine 0.2% Injectable SolutionAlso: PENG blockUltrasound-guided regional anesthesia technique targeting the articular branches of the hip joint to provide postoperative analgesia. | Drug | Spinal Anesthesia + PENG Block |
| 0.9%NaClAlso: Sham ProcedureSimulated procedure performed to maintain blinding without administration of local anesthetic. | Drug | Spinal Anesthesia Alone (Control) |
Primary outcome
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.
18 secondary outcomes
Systemic Inflammation Response Index (SIRI)
Time frame: 24 hours after surgery
Systemic Inflammation Response Index (SIRI)
Time frame: 48 hours after surgery
Aggregate Index of Systemic Inflammation (AISI)
Time frame: 12 hours after surgery
Aggregate Index of Systemic Inflammation (AISI)
Time frame: 24 hours after surgery
Aggregate Index of Systemic Inflammation (AISI)
Time frame: 48 hours after surgery
Platelet Mass Index (PMI)
Time frame: 12 hours after surgery
Platelet Mass Index (PMI)
Time frame: 24 hours after surgery
Platelet Mass Index (PMI)
Time frame: 48 hours after surgery
C-reactive Protein (CRP) Concentration
Time frame: 12 hours after surgery
C-reactive Protein (CRP) Concentration
Time frame: 24 hours after surgery
C-reactive Protein (CRP) Concentration
Time frame: 48 hours after surgery
Postoperative Pain Intensity
Time frame: 4 hours after surgery
Postoperative Pain Intensity
Time frame: 8 hours after surgery
Postoperative Pain Intensity
Time frame: 12 hours after surgery
Postoperative Pain Intensity
Time frame: 24 hours after surgery
Postoperative Pain Intensity
Time frame: 48 hours after surgery
Opioid Consumption
Time frame: 48 hours after surgery
Time to First Rescue Analgesia
Time frame: 48 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: 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.
Related trials for Hip Dysplasia
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
Recruiting
EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))
Osteoarthritis, Traumatic Arthritis
Not yet recruitingObservational study
3D-Printed Pelvic Models for Planning Complex Total Hip Arthroplasty
Developmental Dysplasia of the Hip, Acetabular Bone Loss
Active, not recruitingObservational study
The Medacta Quadra-P Anteverted Study
Arthrosis, Traumatic Arthritis
RecruitingObservational study
The Medacta International SMS Post-Marketing Surveillance Study
Arthrosis, Traumatic Arthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tomasz Reysner, MD PhD contact
Małgorzata Reysner, MD PhD study chair
Poznań University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine 0.2% Injectable Solution and 0.9%NaCl in people with Hip Dysplasia, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Małgorzata Reysner, MD PhD (+48 (61) 831-01-22, mreysner@ump.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic Inflammation Response Index (SIRI) (time frame: 12 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.