Spine Fusion, Spine Disease, Spinal Disease
Conditions
Brief summary
The study aims to assess the interfacial plane blocks' effect on pain level, course of postoperative rehabilitation, and anti-inflammatory analgesic effect.
Detailed description
This study evaluates the analgesic efficacy in adults of bilevel, bilateral erector spinae plane (ESP) blocks after posterior cervical 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
Bilateral ESPB under ultrasound guidance (adjusted to the incision line): 2 x 20ml/kg 0,9% normal saline
DRUG0.2% ropivacaine
Bilateral ESPB under ultrasound guidance (adjusted to the incision line): 2 x 20ml/kg 0,2% ropivacaine
Sponsors
Poznan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* patients undergoing primary posterior cervical decompression and stabilization with instrumentation involving multi-levels in the cervical region, * aged \>18 years and \<100 years * ASA physical status 1, 2 or 3.
Exclusion criteria
* refuse to participate, * history of opioid abuse, * infection of the puncture site, * aged \<18 years and \>100 years * ASA 4 and 5
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| first need of opiate | 48 hours | Time after surgery when the patient needs opiate for the first time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PLR | 12 hours after surgery | Platet-to-lymphocyte ratio |
| Numerical Rating Scale [range 0:10] | 4 hours after surgery | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) |
| NLR | 12 hours after surgery | Neutrophil-to-lymphocyte ratio |
| Opioid consumption | 48 hours | Total opiate consumption after surgery |
Countries
Poland
Contacts
STUDY_CHAIRMalgorzata Domagalska, Ph.D.
Poznań University of Medical Science
Outcome results
None listed