Hip DiseasePhase 4NCT07023094
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
A Phase 4 study testing Ropivacaine 0.2% for PENG Block, Ropivacaine 0.2% for LFCB and Ropivacaine 0.2% for L-ESPB in people with Hip Disease and Hip Dysplasia, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
This randomized controlled trial (RCT) compares the analgesic effectiveness of two regional anesthesia techniques-Pericapsular Nerve Group (PENG) block combined with Lateral Femoral Cutaneous Nerve Block (LFCB) versus Lumbar and Sacral Erector Spinae Plane Blocks (L-ESPB and S-ESPB)-in pediatric patients undergoing… Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Hip Disease, Hip Dysplasia, Hip Arthropathy
- What is being tested?
- Ropivacaine 0.2% for PENG Block, Ropivacaine 0.2% for LFCB and Ropivacaine 0.2% for L-ESPB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 16 Jun 2025to 30 Jun 2026
- Phase
- Phase 4
- 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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients aged between 2 and 16 years.
- Scheduled for elective orthopedic hip surgery, including: Osteotomies and Hip reconstruction surgeries
- ASA (American Society of Anesthesiologists) physical status classification: I-III.
- Written informed consent obtained from the patient's legal guardian(s).
Who cannot join
- Known allergy or hypersensitivity to any of the study medications
- Presence of infection or inflammation at the intended injection site(s) of regional anesthesia.
- Coagulopathy or bleeding disorders (including patients on anticoagulant therapy) that contraindicate nerve blocks.
- Neurological disorders or peripheral neuropathies that could influence sensory or motor assessment of the lower limbs.
- Cognitive impairment or behavioral disorders significantly affecting pain assessment accuracy or cooperation.
- History of chronic opioid use or known substance abuse.
- Severe systemic disease or condition compromising patient safety or interfering with study protocol adherence.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Poznan University of Medical Sciences
Poznan
Malgorzata Reysner, MD. Ph.D., +608762068, mreysner@ump.edu.pl
About this study
Official title: Comparison of Analgesic Efficacy of Pericapsular Nerve Group (PENG) Block With Lateral Femoral Cutaneous Nerve Block (LFCB) Versus Lumbar and Sacral Erector Spinae Plane Blocks (L-ESPB and S-ESPB) in Pediatric Hip Surgery: A Randomized Controlled Trial
This randomized controlled trial (RCT) compares the analgesic effectiveness of two regional anesthesia techniques-Pericapsular Nerve Group (PENG) block combined with Lateral Femoral Cutaneous Nerve Block (LFCB) versus Lumbar and Sacral Erector Spinae Plane Blocks (L-ESPB and S-ESPB)-in pediatric patients undergoing hip surgery.
Read the detailed description
Orthopedic hip procedures in pediatric patients, including osteotomies, arthroscopic interventions, and reconstructive surgeries, often result in significant postoperative pain. Effective analgesia is critical for reducing surgical stress, accelerating rehabilitation, and minimizing opioid use and associated side effects. Regional anesthesia techniques have gained attention for their opioid-sparing effects and enhanced recovery profiles.
This randomized controlled trial aims to compare the analgesic effectiveness of two regional anesthetic approaches:
- The pericapsular nerve group (PENG) block is combined with the lateral fetal cutaneous nerve block (LFCB), targeting hip joint innervation directly and providing comprehensive sensory coverage.
Lumbar and sacral erector spinae plane blocks (L-ESPB and S-ESPB) employ fascial plane techniques to deliver analgesia by diffusing local anesthetic around nerves innervating the hip region.
This trial aims to establish the optimal regional anesthesia technique and determine the clinical benefits of using dexamethasone and dexmedetomidine as adjuvants. The results will guide clinicians toward evidence-based analgesic protocols in pediatric orthopedic hip surgery, potentially reducing opioid-related complications and improving patient recovery outcomes.
- Conditions
- Hip Disease, Hip Dysplasia, Hip Arthropathy
- Being tested
- Ropivacaine 0.2% for PENG Block, Ropivacaine 0.2% for LFCB, Ropivacaine 0.2% for L-ESPB, Ropivacaine 0.2% for S-ESPB
- 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% for PENG BlockDrug
U-S guided PENG (0.4 mL/kg) with 0.2% ropivacaine
Ropivacaine 0.2% for LFCBDrug
LFCB (0.1 mL/kg) with 0.2% ropivacaine
Ropivacaine 0.2% for L-ESPBDrug
Lumbar ESPB (0.25ml/kg) with 0.2% ropivacaine
Ropivacaine 0.2% for S-ESPBDrug
Sacral ESPB (0.25ml/kg) with 0.2% ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| PENG + LFCB | Active comparator | U-S guided PENG block - 0.4ml/kg 0.2% ropivacaine
+ U-S guided LFCB - 0.1ml/kg 0.2% ropivacaine Receives: Drug: Ropivacaine 0.2% for PENG Block; Drug: Ropivacaine 0.2% for LFCB |
| L-ESPB + S-ESPB | Active comparator | U-S guided L-ESPB - 0.25ml/kg 0.2% ropivacaine
+ U-S guided S-ESPB - 0.25ml/kg 0.2% ropivacaine Receives: Drug: Ropivacaine 0.2% for L-ESPB; Drug: Ropivacaine 0.2% for S-ESPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Opioid Consumption
Total opiate consumption after surgery
Measured: 48 hours after surgery
Secondary outcomes (12)
Time to first rescue opioid analgesia
Time after surgery when the patient needs opiate for the first time
Measured: 48 hours after surgery
Numerical Rating Scale [range 0:10]
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
Measured: 4 hours after surgery
Numerical Rating Scale [range 0:10]
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
Measured: 8 hours after surgery
Numerical Rating Scale [range 0:10]
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
Measured: 12 hours after surgery
Numerical Rating Scale [range 0:10]
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
Measured: 24 hours after surgery
Numerical Rating Scale [range 0:10]
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
Measured: 48 hours after surgery
NLR
neutrophile to lymphocyte ratio
Measured: 12 hours after surgery
NLR
neutrophile to lymphocyte ratio
Measured: 24 hours after surgery
NLR
neutrophile to lymphocyte ratio
Measured: 48 hours after surgery
PLR
platelet to lymphocyte ratio
Measured: 12 hours after surgery
PLR
platelet to lymphocyte ratio
Measured: 24 hours after surgery
PLR
platelet to lymphocyte ratio
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 posted15 Jun 2025
- Study start16 Jun 2025
- Primary completion30 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malgorzata Reysner, M.D. Ph.D., Principal investigator, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023094
- Sponsor's protocol ID
- 6/2025
- Status last verified
- Jun 2025
- First submitted
- 8 Jun 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Efficacy of Pericapsular Nerve Group (PENG) Block With Lateral Femoral Cutaneous Nerve Block (LFCB) Versus Lumbar and Sacral Erector Spinae Plane Blocks (L-ESPB and S-ESPB) in Pediatric Hip Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07023094
- Acronym / sponsor ID
- 6/2025
- Conditions
- Hip Disease, Hip Dysplasia, Hip Arthropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 15 Jun 2025 (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 randomized controlled trial (RCT) compares the analgesic effectiveness of two regional anesthesia techniques-Pericapsular Nerve Group (PENG) block combined with Lateral Femoral Cutaneous Nerve Block (LFCB) versus Lumbar and Sacral Erector Spinae Plane Blocks (L-ESPB and S-ESPB)-in pediatric patients undergoing hip surgery.
Detailed description
Orthopedic hip procedures in pediatric patients, including osteotomies, arthroscopic interventions, and reconstructive surgeries, often result in significant postoperative pain. Effective analgesia is critical for reducing surgical stress, accelerating rehabilitation, and minimizing opioid use and associated side effects. Regional anesthesia techniques have gained attention for their opioid-sparing effects and enhanced recovery profiles.
This randomized controlled trial aims to compare the analgesic effectiveness of two regional anesthetic approaches:
- The pericapsular nerve group (PENG) block is combined with the lateral fetal cutaneous nerve block (LFCB), targeting hip joint innervation directly and providing comprehensive sensory coverage.
Lumbar and sacral erector spinae plane blocks (L-ESPB and S-ESPB) employ fascial plane techniques to deliver analgesia by diffusing local anesthetic around nerves innervating the hip region.
This trial aims to establish the optimal regional anesthesia technique and determine the clinical benefits of using dexamethasone and dexmedetomidine as adjuvants. The results will guide clinicians toward evidence-based analgesic protocols in pediatric orthopedic hip surgery, potentially reducing opioid-related complications and improving patient recovery outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PENG + LFCB | Active comparator | Drug: Ropivacaine 0.2% for PENG Block, Drug: Ropivacaine 0.2% for LFCBU-S guided PENG block - 0.4ml/kg 0.2% ropivacaine + U-S guided LFCB - 0.1ml/kg 0.2% ropivacaine |
| L-ESPB + S-ESPB | Active comparator | Drug: Ropivacaine 0.2% for L-ESPB, Drug: Ropivacaine 0.2% for S-ESPBU-S guided L-ESPB - 0.25ml/kg 0.2% ropivacaine + U-S guided S-ESPB - 0.25ml/kg 0.2% ropivacaine |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pediatric patients aged between 2 and 16 years.
- Scheduled for elective orthopedic hip surgery, including: Osteotomies and Hip reconstruction surgeries
- ASA (American Society of Anesthesiologists) physical status classification: I-III.
- Written informed consent obtained from the patient's legal guardian(s).
Key exclusion criteria (7 listed)
- Known allergy or hypersensitivity to any of the study medications
- Presence of infection or inflammation at the intended injection site(s) of regional anesthesia.
- Coagulopathy or bleeding disorders (including patients on anticoagulant therapy) that contraindicate nerve blocks.
- Neurological disorders or peripheral neuropathies that could influence sensory or motor assessment of the lower limbs.
- Cognitive impairment or behavioral disorders significantly affecting pain assessment accuracy or cooperation.
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% for PENG BlockU-S guided PENG (0.4 mL/kg) with 0.2% ropivacaine | Drug | PENG + LFCB |
| Ropivacaine 0.2% for LFCBLFCB (0.1 mL/kg) with 0.2% ropivacaine | Drug | PENG + LFCB |
| Ropivacaine 0.2% for L-ESPBLumbar ESPB (0.25ml/kg) with 0.2% ropivacaine | Drug | L-ESPB + S-ESPB |
| Ropivacaine 0.2% for S-ESPBSacral ESPB (0.25ml/kg) with 0.2% ropivacaine | Drug | L-ESPB + S-ESPB |
Primary outcome
Total Opioid Consumption
Time frame: 48 hours after surgery
Total opiate consumption after surgery
12 secondary outcomes
Time to first rescue opioid analgesia
Time frame: 48 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: 4 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: 8 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: 12 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: 24 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: 48 hours after surgery
NLR
Time frame: 12 hours after surgery
NLR
Time frame: 24 hours after surgery
NLR
Time frame: 48 hours after surgery
PLR
Time frame: 12 hours after surgery
PLR
Time frame: 24 hours after surgery
PLR
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 11 Jul 2025.
- Individual participant dataSharing planned: Yes
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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.
Malgorzata Reysner, M.D. Ph.D. principal investigator
Poznan 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 Phase 4 study testing Ropivacaine 0.2% for PENG Block, Ropivacaine 0.2% for LFCB and Ropivacaine 0.2% for L-ESPB in people with Hip Disease and 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 7 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 11 Jul 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Malgorzata Reysner (+48 61 873 83 03, mreysner@ump.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Opioid Consumption (time frame: 48 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 11 Jul 2025.