Scalp Blocks for Pediatric External Ventricular Drainage Placement

March 25, 2025 updated by: Hande Gurbuz

Anesthesia and Analgesia Methods in Pediatric External Ventricular Drainage Placement

External ventricular drainage (EVD) provides cerebrospinal fluid drainage in hydrocephalus. In adults, the neurosurgeon can place EVD at the bedside. In children, it is mainly preferred to be placed in the operating room under general anesthesia. However, general anesthesia may negatively affect oxygenation (during the intubation period) or cerebral blood flow (due to hypotension). This study investigates the use of regional block methods (without general anesthesia) in children for EVD placement.

Study Overview

Status

Completed

Conditions

Detailed Description

External ventricular drainage (EVD) provides cerebrospinal fluid drainage in hydrocephalus. In adults, EVD can be placed by the neurosurgeon at the bedside. In children, it is mainly preferred to be placed in the operating room under general anesthesia. However, general anesthesia may negatively affect oxygenation during a prolonged intubation period, leading to hypoxemia. Furthermore, hypotensive effects of general anesthesia may cause ischemia due to decreased cerebral blood flow.

Additionally, on the other hand, painful stimuli caused by surgical incisions or pins may cause hemorrhagic events due to a hypertensive period. Therefore, scalp blocks and local anesthetic infiltrations are recommended to prevent such adverse events. Although general anesthesia has been a routine for many anesthesiologists for EVD placement in children, this research hypothesizes that scalp blocks (along with sedatives) can be used as an anesthesia method for EVD placement.

This study investigates the use of regional block methods (to avoid general anesthesia) in children for EVD placement.

Study Type

Observational

Enrollment (Actual)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Yildirim
      • Bursa, Yildirim, Turkey
        • University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children under 18 undergoing external ventricular drainage placement in the operating room between 2021 and 2022 in Bursa Yuksek Ihtisas TRH.

Description

Inclusion Criteria:

  • Children undergoing external ventricular drainage

Exclusion Criteria:

  • Children who were intubated preoperatively.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Scalp Block
Those who underwent surgery with scalp block
Local infiltration
Those who underwent surgery with local anesthetic infiltration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anesthesia method
Time Frame: From enrollment to the end of surgery
The anesthesia method used for the surgery (general anesthesia or sedation)
From enrollment to the end of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic consumption
Time Frame: Postoperative first 24 hours.
Total analgesic consumption within the first 24 in the postoperative period.
Postoperative first 24 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hande Gurbuz

Collaborators

Bursa Yüksek İhtisas Education and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2021

Primary Completion (Actual)

August 28, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

March 24, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

March 31, 2025

Study Record Updates

Last Update Posted (Actual)

March 31, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-KAEK-25 2021/08-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The data sets used in this research may be made available upon reasonable request to the corresponding author.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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