Effects of Scalp Nerve Blocks on Systemic Inflammation

NCT ID: NCT02939833

Last Updated: 2016-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-10-31

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.

Detailed Description

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Conditions

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Meningiomas

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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ropivacaine

patients in this group will receive scalp nerve blocks with 0.5% ropivacaine after anesthesia induction and before skull-pin insertion

Group Type EXPERIMENTAL

Scalp Nerve Blocks With Ropivacaine

Intervention Type PROCEDURE

saline

patients in this group will receive scalp nerve blocks with 0.9% saline after anesthesia induction and before skull-pin insertion

Group Type PLACEBO_COMPARATOR

Scalp Nerve Blocks With Saline

Intervention Type PROCEDURE

Interventions

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Scalp Nerve Blocks With Ropivacaine

Intervention Type PROCEDURE

Scalp Nerve Blocks With Saline

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Renji hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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NB20161010

Identifier Type: -

Identifier Source: org_study_id

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