Hip DysplasiaPhase 4NCT06087549
PENG Block vs. ESP Block for Pediatric Hip Surgery
A Phase 4 study testing Pericapsular nerve group block using 0.2% ropivacaine and Erector Spinae Plane Block using 0.2% ropivacaine in people with Hip Dysplasia and Hip Injuries, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
The study compares the effectiveness and safety of the pericapsular nerve blockade vs. ESPB in pediatric patients who underwent hip surgeries. Read more about this study
- Who is it for?
- Ages 2 months to 12 years
- Conditions the study is for
- Hip Dysplasia, Hip Injuries, Hip Fractures
- What is being tested?
- Pericapsular nerve group block using 0.2% ropivacaine and Erector Spinae Plane Block using 0.2% ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 17 Oct 2023to 23 Feb 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- pediatric patients aged between 0-12 years who will undergo hip surgery
Who cannot join
- a history of chronic pain use of gabapentin/pregabalin for > 3 months opioid use > 1 repeated opioid prescription in the last three months
- morbid obesity (BMI > 99th percentile)
- Infection at block application area
- coagulopathy
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
Poznan, Wielkopolska, 61-545
About this study
Official title: PENG Block vs. ESP Block for Pediatric Hip Surgery. A Randomized, Prospective Double-blinded Clinical Trial.
The study compares the effectiveness and safety of the pericapsular nerve blockade vs. ESPB in pediatric patients who underwent hip surgeries.
Read the detailed description
The study compares the effectiveness and safety of the pericapsular nerve blockade vs. ESPB in pediatric patients who underwent hip surgeries. In addition, we aim to determine the optimal volume of local anesthetics needed to achieve a satisfactory level of analgesia.
- Conditions
- Hip Dysplasia, Hip Injuries, Hip Fractures, Hip Disease
- Being tested
- Pericapsular nerve group block using 0.2% ropivacaine, Erector Spinae Plane Block using 0.2% ropivacaine, Standard care
- Medical subject headings
- Hip Dislocation, Hip Injuries, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericapsular nerve group block using 0.2% ropivacaineDrug
Unilateral ultrasound guided pericapsular nerve block using 0.5mL/kg 0.2% Ropimol (max 20mL)
Erector Spinae Plane Block using 0.2% ropivacaineDrug
Unilateral ultrasound guided erector spinae block using 0.5mL/kg 0.2% Ropimol (max 20mL)
Standard careOther
Also called No erector spinae block and no pericapsular nerve group block
No erector spinae block and no pericapsular nerve group block
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | regional anesthesia: spinal anesthesia - 0,1ml/kg 0,5% ropivacaine Receives: Other: Standard care |
| Pericapsular nerve group block (PENG) group | Active comparator | regional anesthesia: spinal anesthesia - 0,1ml/kg 0,5% ropivacaine + PENG block - 0.5mL/kg 0.2% ropivacaine, max. 20mL Receives: Drug: Pericapsular nerve group block using 0.2% ropivacaine |
| Erector Spinae Plane Block (ESPB) group | Active comparator | regional anesthesia: spinal anesthesia - 0,1ml/kg 0,5% ropivacaine + ESP block - 0.5mL/kg 0.2% ropivacaine, max. 20mL Receives: Drug: Erector Spinae Plane Block using 0.2% ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
FLACC score
The FLACC scale or Face, Legs, Activity, Cry, Controllability Scale is used to assess pain for children between the ages of 2 months and seven years or individuals unable to communicate their pain. The scale is scored in a range of 0-10, with 0 representing no pain.
Measured: 48 hours after surgery
Secondary outcomes (3)
NLR
neutrophil-to-lymphocyte ratio
Measured: 48 hours after surgery
PLR
platelet-to-lymphocyte ratio
Measured: 48 hours after surgery
total opioid consumption
morphine equivalents in miligrams
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 posted17 Oct 2023
- Study start17 Oct 2023
- Primary completion23 Feb 2024
- Study completion23 Feb 2024
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups: Group I -control Group II - PENG block Group III - ESP block
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tomasz Kotwicki, Prof.dr hab, Study chair, Poznań University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087549
- Sponsor's protocol ID
- 4/2023
- Status last verified
- Feb 2024
- First submitted
- 5 Jul 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PENG Block vs. ESP Block for Pediatric Hip Surgery. A Randomized, Prospective Double-blinded Clinical Trial.
- ClinicalTrials.gov ID
- NCT06087549
- Acronym / sponsor ID
- 4/2023
- Conditions
- Hip Dysplasia, Hip Injuries, Hip Fractures, Hip Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 17 Oct 2023 (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.
The study compares the effectiveness and safety of the pericapsular nerve blockade vs. ESPB in pediatric patients who underwent hip surgeries.
Detailed description
The study compares the effectiveness and safety of the pericapsular nerve blockade vs. ESPB in pediatric patients who underwent hip surgeries. In addition, we aim to determine the optimal volume of local anesthetics needed to achieve a satisfactory level of analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Three groups: Group I -control Group II - PENG block Group III - ESP block
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Standard careregional anesthesia: spinal anesthesia - 0,1ml/kg 0,5% ropivacaine |
| Pericapsular nerve group block (PENG) group | Active comparator | Drug: Pericapsular nerve group block using 0.2% ropivacaineregional anesthesia: spinal anesthesia - 0,1ml/kg 0,5% ropivacaine + PENG block - 0.5mL/kg 0.2% ropivacaine, max. 20mL |
| Erector Spinae Plane Block (ESPB) group | Active comparator | Drug: Erector Spinae Plane Block using 0.2% ropivacaineregional anesthesia: spinal anesthesia - 0,1ml/kg 0,5% ropivacaine + ESP block - 0.5mL/kg 0.2% ropivacaine, max. 20mL |
Who may qualify
- Ages
- 2 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- pediatric patients aged between 0-12 years who will undergo hip surgery
Key exclusion criteria (4 listed)
- a history of chronic pain use of gabapentin/pregabalin for > 3 months opioid use > 1 repeated opioid prescription in the last three months
- morbid obesity (BMI > 99th percentile)
- Infection at block application area
- coagulopathy
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 |
|---|---|---|
| Pericapsular nerve group block using 0.2% ropivacaineUnilateral ultrasound guided pericapsular nerve block using 0.5mL/kg 0.2% Ropimol (max 20mL) | Drug | Pericapsular nerve group block (PENG) group |
| Erector Spinae Plane Block using 0.2% ropivacaineUnilateral ultrasound guided erector spinae block using 0.5mL/kg 0.2% Ropimol (max 20mL) | Drug | Erector Spinae Plane Block (ESPB) group |
| Standard careAlso: No erector spinae block and no pericapsular nerve group blockNo erector spinae block and no pericapsular nerve group block | Other | Control group |
Primary outcome
FLACC score
Time frame: 48 hours after surgery
The FLACC scale or Face, Legs, Activity, Cry, Controllability Scale is used to assess pain for children between the ages of 2 months and seven years or individuals unable to communicate their pain. The scale is scored in a range of 0-10, with 0 representing no pain.
3 secondary outcomes
NLR
Time frame: 48 hours after surgery
PLR
Time frame: 48 hours after surgery
total opioid consumption
Time frame: 48 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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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. This study is not recruiting at the moment.
Tomasz Kotwicki, Prof.dr hab 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 Phase 4 study testing Pericapsular nerve group block using 0.2% ropivacaine and Erector Spinae Plane Block using 0.2% ropivacaine in people with Hip Dysplasia and Hip Injuries, 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 28 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FLACC score (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 28 Feb 2024.