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Scalp Blocks for Pediatric External Ventricular Drainage Placement

NCT ID: NCT06903598

Last Updated: 2025-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-25

Study Completion Date

2022-09-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hydrocephalus in Children Regional Block Pediatric Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Scalp Block

Those who underwent surgery with scalp block

No interventions assigned to this group

Local infiltration

Those who underwent surgery with local anesthetic infiltration

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Children undergoing external ventricular drainage

Exclusion Criteria

* Children who were intubated preoperatively.
Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role collaborator

Hande Gurbuz

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hande Gurbuz

Assoc. Prof., MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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

Bursa, Yildirim, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Rigamonti A, Garavaglia MM, Ma K, Crescini C, Mistry N, Thorpe K, Cusimano MD, Das S, Hare GMT, Mazer CD. Effect of bilateral scalp nerve blocks on postoperative pain and discharge times in patients undergoing supratentorial craniotomy and general anesthesia: a randomized-controlled trial. Can J Anaesth. 2020 Apr;67(4):452-461. doi: 10.1007/s12630-019-01558-7. Epub 2019 Dec 26.

Reference Type BACKGROUND
PMID: 31879855 (View on PubMed)

Carella M, Tran G, Bonhomme VL, Franssen C. Influence of Levobupivacaine Regional Scalp Block on Hemodynamic Stability, Intra- and Postoperative Opioid Consumption in Supratentorial Craniotomies: A Randomized Controlled Trial. Anesth Analg. 2021 Feb 1;132(2):500-511. doi: 10.1213/ANE.0000000000005230.

Reference Type BACKGROUND
PMID: 33060491 (View on PubMed)

Lamsal R, Rath GP. Pediatric neuroanesthesia. Curr Opin Anaesthesiol. 2018 Oct;31(5):539-543. doi: 10.1097/ACO.0000000000000630.

Reference Type BACKGROUND
PMID: 29985182 (View on PubMed)

van Lindert EJ, Liem KD, Geerlings M, Delye H. Bedside placement of ventricular access devices under local anaesthesia in neonates with posthaemorrhagic hydrocephalus: preliminary experience. Childs Nerv Syst. 2019 Dec;35(12):2307-2312. doi: 10.1007/s00381-019-04361-3. Epub 2019 Sep 10.

Reference Type BACKGROUND
PMID: 31506779 (View on PubMed)

Other Identifiers

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2011-KAEK-25 2021/08-24

Identifier Type: -

Identifier Source: org_study_id