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Study aim
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Investigating the effect of erector spinae plane block during posterior cervical spine fusion surgery with lateral mass fixation on postoperative occipital pain.
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Design
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clinical trial included a control group and parallel, double-blind, randomized, phase 2 groups, conducted on 60 patients. Block randomization method was used for randomization.
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Settings and conduct
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The study is designed to be conducted on two groups of patients undergoing posterior cervical spine fusion surgery with lateral mass fixation. A total of 60 patients will be assigned to the intervention and control groups using block randomization. One group of 30 patients will receive injections of bupivacaine and dexamethasone into the erector spinae muscles, while the other group of 30 patients will receive a placebo. The study will be double-blind, meaning that the patient, investigator, drug injector, and statistical analyst will be blinded.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:Absence of lower limb paralysis before surgery, age between 18 and 65 years, fusion in the range of C3 to C7
Exclusion criteria:Pregnancy, decreased lower limb force after surgery, acute neck trauma, site infection, simultaneous anterior cervical surgery, patient's reason for surgery is tumor addiction to drugs (excluding smoking)
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Intervention groups
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In the intervention group, a combination of bupivacaine and dexamethasone is injected throughout the muscles at the site of skin incision, but in the control group, a placebo is injected.
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Main outcome variables
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NRS scores at 6 hours, 24 hours, 48 hours, and 1 week after surgery؛ the first time the patient requested analgesics؛ the amount and type of analgesic used؛ the time to first ambulation after surgery؛ age؛ gender؛ number of cervical fusion levels؛ smoking status؛ presence of myelopathy changes in MRI؛ presence of radicular pain؛ and type of underlying pathology