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The study compares the effectiveness and safety of the pericapsular nerve blockade vs. ESPB in pediatric patients who underwent hip surgeries.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | regional anesthesia: spinal anesthesia - 0,1ml/kg 0,5% ropivacaine |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pericapsular nerve group block using 0.2% ropivacaine | Drug | Unilateral ultrasound guided pericapsular nerve block using 0.5mL/kg 0.2% Ropimol (max 20mL) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| NLR | neutrophil-to-lymphocyte ratio | 48 hours after surgery |
| PLR | platelet-to-lymphocyte ratio | 48 hours after surgery |
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Inclusion Criteria:
- pediatric patients aged between 0-12 years who will undergo hip surgery
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomasz Kotwicki, Prof.dr hab | Poznań University of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland | Poznan | Wielkopolska | 61-545 | Poland |
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| ID | Term |
|---|---|
| D006617 | Hip Dislocation |
| D025981 | Hip Injuries |
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Three groups:
Group I -control Group II - PENG block Group III - ESP block
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Patients will be randomly allocated to receive ultrasound-guided PENG block, ESP block, or only spinal anesthesia by computer software 1:1:1. A researcher who will not involve in the study will prepare the randomization list and concealed group assignments in consecutively numbered, sealed, opaque envelopes. A consultant anesthesiologist will follow management to open the envelopes shortly before the nerve block performance to reveal the group allocation and perform the procedure according to the assignment. The patients and their anesthesia team, surgeon, operating room staff, and parents will be masked to the study group allocation. Group blinding unmasking will only occur once the statistical analysis is complete.
| Erector Spinae Plane Block using 0.2% ropivacaine | Drug | Unilateral ultrasound guided erector spinae block using 0.5mL/kg 0.2% Ropimol (max 20mL) |
|
| Standard care | Other | No erector spinae block and no pericapsular nerve group block |
|
|
| total opioid consumption | morphine equivalents in miligrams | 48 hours after surgery |
| D005264 |
| Femoral Fractures |
| D050723 | Fractures, Bone |
| D007869 | Leg Injuries |
| D000588 |
| Amines |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |