Effects of Scalp Nerve Blocks on Systemic Inflammation

Effects of Scalp Nerve Blocks on Systemic Inflammation After Meningeoma Resection Surgery：a Prospective Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Meningiomas
• Intervention / Treatment: Procedure: Scalp Nerve Blocks With Ropivacaine; Procedure: Scalp Nerve Blocks With Saline

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Shanghai Renji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ropivacaine; patients in this group will receive scalp nerve blocks with 0.5% ropivacaine after anesthesia induction and before skull-pin insertion	Procedure: Scalp Nerve Blocks With Ropivacaine
Placebo Comparator: saline; patients in this group will receive scalp nerve blocks with 0.9% saline after anesthesia induction and before skull-pin insertion	Procedure: Scalp Nerve Blocks With Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
serum TNF-α level	1 hour after surgery
serum IL-6 level	1 hour after surgery
serum IL-1β level	1 hour after surgery
serum TNF-α level	72 hour after surgery
serum IL-6 level	72 hour after surgery
serum IL-1β level	72 hour after surgery
VAS score	24 hour after surgery
VAS score	48 hour after surgery
VAS score	72 hour after surgery
dosage of pain-control medicine	within 72 hour after surgery
NRS score	24 hour after surgery
NRS score	48 hour after surgery
NRS score	72 hour after surgery
incidence of intracranial infection	within 30 days after surgery
Hospitalization Days	up to 30 days
out of pocket expenditure for hospitalisation	hospital discharge/up to 30 days

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: October 11, 2016
• First Submitted That Met QC Criteria: October 18, 2016
• First Posted (Estimate): October 20, 2016

Study Record Updates

• Last Update Posted (Estimate): October 20, 2016
• Last Update Submitted That Met QC Criteria: October 18, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Inflammation; Meningioma; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: NB20161010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED