Scoliosis Idiopathic
Conditions
Keywords
pain management, peripheral nerve block, erector spinae plane block, euromonitoring
Brief summary
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.
Detailed description
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.
Interventions
DRUGSham block
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
DRUGESPB
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)
Sponsors
Poznan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* age 10-18 years old * pediatric patients who will undergo the surgical correction of idiopathic scoliosis
Exclusion criteria
* a history of chronic pain (use of gabapentin/pregabalin for \> 3 months or opioid use \> 1 repeated opioid prescription in the last three months) * morbid obesity (BMI \> 99th percentile) * previous surgery * back abnormalities * infection at block application area * coagulopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Numerical Rating Scale | 30 minutes after surgery | Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motor Evoked Potential amplitude | up to seven days prior to the correction of scoliosis | Motor Evoked Potentials durring surgery |
| total opioid consumption | Day 1 after surgery | intravenous milligrams of morphine equivalents |
| neutrophil/lymphocyte ratio | 12 hours and 24 hours after surgery | neutrophil/lymphocyte ratio |
| platelet/lymphocyte ratio | 12 hours and 24 hours after surgery | platelet/lymphocyte ratio |
| Nausea or Vomiting | during first 24 hours after surgery | presence or absence |
Countries
Poland
Contacts
Primary ContactMagorzata Domagalska, Ph.D.
Outcome results
None listed