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Effects of Scalp Nerve Blocks on Systemic Inflammation

Primary Purpose

Meningiomas

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Scalp Nerve Blocks With Ropivacaine
Scalp Nerve Blocks With Saline
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meningiomas

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Renji hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ropivacaine

saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

serum TNF-α level
serum IL-6 level
serum IL-1β level

Secondary Outcome Measures

serum TNF-α level
serum IL-6 level
serum IL-1β level
serum TNF-α level
serum IL-6 level
serum IL-1β level
VAS score
VAS score
VAS score
dosage of pain-control medicine
NRS score
NRS score
NRS score
incidence of intracranial infection
Hospitalization Days
out of pocket expenditure for hospitalisation

Full Information

First Posted
October 11, 2016
Last Updated
October 18, 2016
Sponsor
RenJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02939833
Brief Title
Effects of Scalp Nerve Blocks on Systemic Inflammation
Official Title
Effects of Scalp Nerve Blocks on Systemic Inflammation After Meningeoma Resection Surgery:a Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningiomas

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ropivacaine
Arm Type
Experimental
Arm Description
patients in this group will receive scalp nerve blocks with 0.5% ropivacaine after anesthesia induction and before skull-pin insertion
Arm Title
saline
Arm Type
Placebo Comparator
Arm Description
patients in this group will receive scalp nerve blocks with 0.9% saline after anesthesia induction and before skull-pin insertion
Intervention Type
Procedure
Intervention Name(s)
Scalp Nerve Blocks With Ropivacaine
Intervention Type
Procedure
Intervention Name(s)
Scalp Nerve Blocks With Saline
Primary Outcome Measure Information:
Title
serum TNF-α level
Time Frame
24 hour after surgery
Title
serum IL-6 level
Time Frame
24 hour after surgery
Title
serum IL-1β level
Time Frame
24 hour after surgery
Secondary Outcome Measure Information:
Title
serum TNF-α level
Time Frame
1 hour after surgery
Title
serum IL-6 level
Time Frame
1 hour after surgery
Title
serum IL-1β level
Time Frame
1 hour after surgery
Title
serum TNF-α level
Time Frame
72 hour after surgery
Title
serum IL-6 level
Time Frame
72 hour after surgery
Title
serum IL-1β level
Time Frame
72 hour after surgery
Title
VAS score
Time Frame
24 hour after surgery
Title
VAS score
Time Frame
48 hour after surgery
Title
VAS score
Time Frame
72 hour after surgery
Title
dosage of pain-control medicine
Time Frame
within 72 hour after surgery
Title
NRS score
Time Frame
24 hour after surgery
Title
NRS score
Time Frame
48 hour after surgery
Title
NRS score
Time Frame
72 hour after surgery
Title
incidence of intracranial infection
Time Frame
within 30 days after surgery
Title
Hospitalization Days
Time Frame
up to 30 days
Title
out of pocket expenditure for hospitalisation
Time Frame
hospital discharge/up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Shanghai Renji hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effects of Scalp Nerve Blocks on Systemic Inflammation

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