Effects of Scalp Nerve Blocks on Systemic Inflammation

Study Overview
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Brief Summary
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Patients undergoing meningeoma resection surgery will be randomly assigned to two groups. One group will receive scalp nerve blocks with 0.5% ropivacaine, whereas the other group will receive scalp nerve blocks with 0.9% saline after anesthesia induction and before skull-pin insertion. Serum levels of TNF-α、IL-6 and IL-1β will be measured and compared at before surgery, 1h, 24h and 72h after surgery, respectively. VAS score, dosage of pain-control medicine and NRS score at the first three days after surgery, ratio of intracranial infection within 30d after surgery, and total hospitalization days and medical expenditure will also be recorded and compared between the two groups.

Official Title
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Effects of Scalp Nerve Blocks on Systemic Inflammation After Meningeoma Resection Surgery：a Prospective Randomized Controlled Trial

Conditions
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Meningiomas

Intervention / Treatment
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* Procedure: Scalp Nerve Blocks With Ropivacaine
* Procedure: Scalp Nerve Blocks With Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 18-28 kg/m2 ASA Physical Status 1-2 diagnosed Meningeoma and will have selective Meningeoma Resection Surgery the incision will be conducted at the frontal, top or the temperal skull. Exclusion Criteria: previous brain surgery severe systemic disease (heart, lung, kidney, or immune system) nerval or mental disorders a history of addiction to opioids allergic to ropivacaine infection at block site or severe systemic infection refuse to attend the trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ropivacaine<br>patients in this group will receive scalp nerve blocks with 0.5% ropivacaine after anesthesia induction and before skull-pin insertion | Procedure: Scalp Nerve Blocks With Ropivacaine<br> <br> |
| Placebo Comparator: saline<br>patients in this group will receive scalp nerve blocks with 0.9% saline after anesthesia induction and before skull-pin insertion | Procedure: Scalp Nerve Blocks With Saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum TNF-α level |  | 24 hour after surgery | 
| serum IL-6 level |  | 24 hour after surgery | 
| serum IL-1β level |  | 24 hour after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum TNF-α level |  | 1 hour after surgery | 
| serum IL-6 level |  | 1 hour after surgery | 
| serum IL-1β level |  | 1 hour after surgery | 
| serum TNF-α level |  | 72 hour after surgery | 
| serum IL-6 level |  | 72 hour after surgery | 
| serum IL-1β level |  | 72 hour after surgery | 
| VAS score |  | 24 hour after surgery | 
| VAS score |  | 48 hour after surgery | 
| VAS score |  | 72 hour after surgery | 
| dosage of pain-control medicine |  | within 72 hour after surgery | 
| NRS score |  | 24 hour after surgery | 
| NRS score |  | 48 hour after surgery | 
| NRS score |  | 72 hour after surgery | 
| incidence of intracranial infection |  | within 30 days after surgery | 
| Hospitalization Days |  | up to 30 days | 
| out of pocket expenditure for hospitalisation |  | hospital discharge/up to 30 days |