NCT02939833

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 20, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

October 20, 2016

Status Verified

October 1, 2016

Enrollment Period

2.4 years

First QC Date

October 11, 2016

Last Update Submit

October 18, 2016

Conditions

Meningiomas

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (16)

  • 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

  • +11 more secondary outcomes

Study Arms (2)

ropivacaine

EXPERIMENTAL

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

saline

PLACEBO COMPARATOR

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

Interventions

Scalp Nerve Blocks With RopivacainePROCEDURE
ropivacaine
Scalp Nerve Blocks With SalinePROCEDURE
saline

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Renji hospital

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Meningioma

Interventions

RopivacaineSodium Chloride

Condition Hierarchy (Ancestors)

Neoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular TissueMeningeal NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNervous System Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2016

First Posted

October 20, 2016

Study Start

January 1, 2017

Primary Completion

June 1, 2019

Study Completion

October 1, 2019

Last Updated

October 20, 2016

Record last verified: 2016-10

Locations

CN(1)