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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ropivacaine | Experimental | After anesthesia induction but before skull-pin insertion, patients in this group will receive scalp nerve blocks with 0.5% ropivacaine |
|
| saline | Placebo Comparator | After anesthesia induction but before skull-pin insertion, patients in this group will receive scalp nerve blocks with 0.9% saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ropivacaine | Procedure | To perform scalp nerve blocks with ropivacaine |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital affliated to Shanghai Jiaotong University School of Medicine | Shanghai | 200127 | China |
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| ID | Term |
|---|---|
| D008579 | Meningioma |
| ID | Term |
|---|---|
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009383 | Neoplasms, Vascular Tissue |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| saline |
| Procedure |
To perform scalp nerve blocks with saline |
|
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 |
| D008577 | Meningeal Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009422 | Nervous System Diseases |
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |