Effects of Scalp Nerve Block With Ropivacaine on Postoperative Recovery Quality

Study Overview
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Brief Summary
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Patients undergoing elective meningeoma resection surgery will be randomly assigned to one of the following two groups. After anesthesia induction but before skull-pin insertion, one group will receive scalp nerve blocks with 0.5% ropivacaine, whereas the other group will receive scalp nerve blocks with 0.9% saline. The patients' postoperative recovery quality, which is evaluated by KPS score, peri-operative inflammatory responses, and post-operative pain degree will be evaluated and compared between the two groups.

Detailed Description
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Patients undergoing elective meningeoma resection surgery will be randomly assigned to one of the following two groups. After anesthesia induction but before skull-pin insertion, one group will receive scalp nerve blocks with 0.5% ropivacaine, whereas the other group will receive scalp nerve blocks with 0.9% saline. The patients' KPS scores at 3d after surgery and at discharge, serum levels of TNF-α、IL-6，IL-1β at 24h after surgery, satisfaction score after recovery, and VAS scores at 1, 2, 3 days post-surgery will be evaluated and compared between the two groups.

Official Title
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Effects of Preoperative Scalp Nerve Block on Postoperative Recovery Quality in Patients Undergoing Excision of Intracranial Meningioma

Conditions
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Meningioma

Intervention / Treatment
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* Procedure: ropivacaine
* Procedure: saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-75 years old; BMI 18-28 kg/m2; ASA Physical Status 1-2; Clinical diagnosis of primary Meningeoma and will have elective Meningeoma Resection Surgery; With an estimated surgery time of less than 4h; The incision will be conducted at the frontal, top or the temperal skull. Exclusion Criteria: A history of 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: 75 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ropivacaine<br>After anesthesia induction but before skull-pin insertion, patients in this group will receive scalp nerve blocks with 0.5% ropivacaine | Procedure: ropivacaine<br>* To perform scalp nerve blocks with ropivacaine<br>|
| Placebo Comparator: saline<br>After anesthesia induction but before skull-pin insertion, patients in this group will receive scalp nerve blocks with 0.9% saline | Procedure: saline<br>* To perform scalp nerve blocks with saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KPS score | Karnofsky performance score (KPS) allows patients to be classified as to their functional impairment. The total scale range is 0-100. The lower the KPS score, the worse the survival for most serious illnesses. | 7 days post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KPS score | Karnofsky performance score (KPS) allows patients to be classified as to their functional impairment. The total scale range is 0-100. The lower the KPS score, the worse the survival for most serious illnesses. | 3 days post-surgery | 
| serum TNF-α levels | an inflammatory mediator that reflects systemic inflammation | at 1h and 24h post-surgery | 
| serum IL-6 levels | an inflammatory mediator that reflects systemic inflammation | at 1h and 24h post-surgery | 
| serum IL-1β levels | an inflammatory mediator that reflects systemic inflammation | at 1h and 24h post-surgery | 
| Iowa Satisfaction with Anesthesia Scale (ISAS) | Iowa Satisfaction with Anesthesia Scale (ISAS) comprises of 11 items to measure patient satisfaction after surgery. The total scale range is -33-+33. The higher the ISAS score, the better the satisfaction level. | 1 hour after the surgery is finished | 
| white blood cell | serum white blood cell count | at 24 h after surgery | 
| serum levels of CRP | inflammatory responses | at 24 h after surgery | 
| VAS score | The visual analogue scale or visual analog scale (VAS) measures the average intensity of pain in the past on a 0-to-10 scale, where 0 = No pain and 10 = Pain as intense as you can imagine. | at 1, 2 and 3 days post-surgery | 
| pain-relief medications | amounts of pain-relief medications | at 1, 2 and 3 days post-surgery | 
| Hospitalization Days | length of hospitalization | up to 30 days | 
| out of pocket expenditure for hospitalisation | This reflects how much money the patient spends during hospitalisation | hospital discharge/up to 30 days | 
| complications | incidence of intracranial infection | within 30 days after surgery |