Effects of Scalp Nerve Blocks on Systemic Inflammation

Not Applicable

• Conditions: Meningiomas
• Interventions: Procedure: Scalp Nerve Blocks With Ropivacaine; Procedure: Scalp Nerve Blocks With Saline

• Registration Number: NCT02939833
• Lead Sponsor: RenJi Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2016-10-18
• Last Update Submitted: 2016-10-18
• Study First Posted: 2016-10-20
• Last Update Posted: 2016-10-20
• Study Start: 2017-01
• Primary Completion: 2019-06
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ropivacaine	Scalp Nerve Blocks With Ropivacaine	patients in this group will receive scalp nerve blocks with 0.5% ropivacaine after anesthesia induction and before skull-pin insertion
saline	Scalp Nerve Blocks With Saline	patients in this group will receive scalp nerve blocks with 0.9% saline after anesthesia induction and before skull-pin insertion

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Shanghai Renji hospital; 🇨🇳 Shanghai, Shanghai, China