Poznan University of Medical Sciences
Poznan, Poznań, 61-701, Poland
NCT Number: NCT06393530
The study aims to assess the interfacial plane blocks' effect on pain level, course of postoperative rehabilitation, and anti-inflammatory analgesic effect.
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Notify Me18 year–100 year
All sexes
Interventional
Phase 4
Poznan, Poznań, 61-701, Poland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Bilateral ESPB under ultrasound guidance (adjusted to the incision line): 2 x 20ml/kg 0,9% normal saline
Other names: 0,9% normal saline
Bilateral ESPB under ultrasound guidance (adjusted to the incision line): 2 x 20ml/kg 0,2% ropivacaine
Other names: 0,2% ropivacaine
Time frame: 48 hours
Time after surgery when the patient needs opiate for the first time
Time frame: 48 hours
Total opiate consumption after surgery
Time frame: 4 hours after surgery
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Time frame: 8 hours after surgery
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Time frame: 12 hours after surgery
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Time frame: 16 hours after surgery
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Time frame: 20 hours after surgery
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Time frame: 24 hours after surgery
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Time frame: 36 hours after surgery
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Time frame: 48 hours after surgery
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Time frame: 12 hours after surgery
Neutrophil-to-lymphocyte ratio
Time frame: 24 hours after surgery
Neutrophil-to-lymphocyte ratio
Time frame: 48 hours after surgery
Neutrophil-to-lymphocyte ratio
Time frame: 12 hours after surgery
Platet-to-lymphocyte ratio
Time frame: 24 hours after surgery
Platet-to-lymphocyte ratio
Time frame: 48 hours after surgery
Platet-to-lymphocyte ratio
Poznan University of Medical Sciences
Other
Erector Spinae Plane Block for Cervical Spine Surgery. A Prospective, Randomized, Double-blinded Clinical Trial.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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