Back to results

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

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

dosage of pain-control medicine

NRS score

incidence of intracranial infection

Hospitalization Days

out of pocket expenditure for hospitalisation

Full Information

NCT ID

NCT02939833

First Posted

October 11, 2016

Last Updated

October 18, 2016

Sponsor

RenJi Hospital

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

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

Learn more about this trial

Effects of Scalp Nerve Blocks on Systemic Inflammation

We'll reach out to this number within 24 hrs