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The study aims to assess the effect of the interfacial plane blocks on the pain level, the course of postoperative rehabilitation, and its anti-inflammatory analgesic effect.
This study evaluates the analgesic efficacy in adolescents of bilevel, bilateral erector spinae plane (ESP) blocks after posterior spinal fusion surgery by assessing postoperative pain scores and opiate requirements as the primary outcome measures. We aim to investigate how ESP blocks, performed under ultrasound guidance at the two vertebral levels, contribute to postoperative pain control. This will be determined by measuring numerical rating pain scores repeatedly following surgery and opiate consumption until the patient is discharged from the hospital. These primary outcome measures will be compared between a treatment group of participants receiving ESP blocks and a control group receiving a sham block. Our primary hypothesis is that ESP blocks significantly reduce postoperative pain and opiate requirements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham group | Active Comparator | Bilateral ESPB under ultrasound guidance bi-level Th3-6 and Th9-L1(adjusted to the incision line): 0.3-0.5ml/kg 0,9% Normal Saline |
|
| ESPB group | Active Comparator | Bilateral ESPB under ultrasound guidance bi-level Th3-6 and Th9-L1(adjusted to the incision line): 0.3-0.5ml/kg 0.2% Ropivacaine (max 2.5mg/kg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham block | Drug | Bilateral ESPB under ultrasound guidance bi-level Th3-6 and Th9-L1(adjusted to the incision line): 0.3-0.5ml/kg 0,9% normal saline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Numerical Rating Scale | Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain) | 30 minutes after surgery |
| Pain Numerical Rating Scale | Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain) | 60 minutes after surgery |
| Pain Numerical Rating Scale | Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain) | 90 minutes after surgery |
| Pain Numerical Rating Scale | Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain) | 120 minutes after surgery |
| Pain Numerical Rating Scale | Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain) | 6 hours after surgery |
| Pain Numerical Rating Scale | Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain) | 12 hours hours after surgery |
| Pain Numerical Rating Scale | Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain) | 24 hours after surgery |
| Pain Numerical Rating Scale | Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain) |
| Measure | Description | Time Frame |
|---|---|---|
| neutrophil/lymphocyte ratio | neutrophil/lymphocyte ratio | 12 hours and 24 hours after surgery |
| platelet/lymphocyte ratio | platelet/lymphocyte ratio |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Magorzata Domagalska, Ph.D. | Contact | 0048608762068 | m.domagalska@icloud.com |
| Name | Affiliation | Role |
|---|---|---|
| Tomasz Kotwicki, Ph.D. | Poznań University of Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland | Recruiting | Poznan | Wielkopolska | 61-545 | Poland |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Patients will be randomly allocated to receive ultrasound-guided ESP block with 0,2% ropivacaine or ESP block with the sham block by computer software 1:1. A researcher who will not be involved 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 surgeon, patients, and anesthesia team will be masked to the study group. Group blinding unmasking will only occur once the statistical analysis is complete.
| ESPB | Drug | Bilateral ESPB under ultrasound guidance bi-level Th3-6 and Th9-L1(adjusted to the incision line): 0.3-0.5ml/kg 0.2% Ropivacaine (max 2.5mg/kg) |
|
|
| 48 hours after surgery |
| 12 hours and 24 hours after surgery |
| Nausea or Vomiting | presence or absence | during first 24 hours after surgery |
| total opioid consumption | intravenous milligrams of morphine equivalents | Day 1 after surgery |
| total opioid consumption | intravenous milligrams of morphine equivalents | Day 2 after surgery |
| total opioid consumption | intravenous milligrams of morphine equivalents | Day 3 after surgery |
| total opioid consumption | intravenous milligrams of morphine equivalents | Day 4 after surgery |
| total opioid consumption | intravenous milligrams of morphine equivalents | Day 5 after surgery |
| total opioid consumption | intravenous milligrams of morphine equivalents | Day 6 after surgery |
| total opioid consumption | intravenous milligrams of morphine equivalents | Day 7 after surgery |
| Motor Evoked Potential amplitude | Motor Evoked Potentials durring surgery | up to seven days prior to the correction of scoliosis |
| Motor Evoked Potential amplitude | Motor Evoked Potentials during surgery | up to 24 weeks following the correction of scoliosis |
| Poznan University of Medical Sciences | Recruiting | Poznan | Poland |
|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |