Spine Fusion Clinical Trial
Official title:
Erector Spinae Plane Block for Cervical Spine Surgery. A Prospective, Randomized, Double-blinded Clinical Trial.
The study aims to assess the interfacial plane blocks' effect on pain level, course of postoperative rehabilitation, and anti-inflammatory analgesic effect.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | June 30, 2025 |
Est. primary completion date | May 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Poland | Poznan University of Medical Sciences | Poznan | Poznan |
Lead Sponsor | Collaborator |
---|---|
Poznan University of Medical Sciences |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | first need of opiate | Time after surgery when the patient needs opiate for the first time | 48 hours | |
Secondary | Opioid consumption | Total opiate consumption after surgery | 48 hours | |
Secondary | Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | 4 hours after surgery | |
Secondary | Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | 8 hours after surgery | |
Secondary | Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | 12 hours after surgery | |
Secondary | Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | 16 hours after surgery | |
Secondary | Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | 20 hours after surgery | |
Secondary | Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | 24 hours after surgery | |
Secondary | Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | 36 hours after surgery | |
Secondary | Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | 48 hours after surgery | |
Secondary | NLR | Neutrophil-to-lymphocyte ratio | 12 hours after surgery | |
Secondary | NLR | Neutrophil-to-lymphocyte ratio | 24 hours after surgery | |
Secondary | NLR | Neutrophil-to-lymphocyte ratio | 48 hours after surgery | |
Secondary | PLR | Platet-to-lymphocyte ratio | 12 hours after surgery | |
Secondary | PLR | Platet-to-lymphocyte ratio | 24 hours after surgery | |
Secondary | PLR | Platet-to-lymphocyte ratio | 48 hours after surgery |
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