Scalp Blocks for Pediatric External Ventricular Drainage Placement

NCT06903598 | Completed

• 1 other identifier: 2011-KAEK-25 2021/08-24
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hydrocephalus in Children; Regional Block; Pediatric Anesthesia

Outcome Measures

Primary Outcomes (1)

• Anesthesia method

  The anesthesia method used for the surgery (general anesthesia or sedation)

  From enrollment to the end of surgery

Secondary Outcomes (1)

• Analgesic consumption

  Postoperative first 24 hours.

Study Arms (2)

Scalp Block

Those who underwent surgery with scalp block

Local infiltration

Those who underwent surgery with local anesthetic infiltration

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Children undergoing external ventricular drainage

You may not qualify if:

• Children who were intubated preoperatively.

Sponsors & Collaborators

• Hande Gurbuz: lead
• Bursa Yuksek Ihtisas Training and Research Hospital: collaborator

Study Sites (1)

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

Bursa, Yildirim, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 31879855 BACKGROUND

• 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.

  PMID: 33060491 BACKGROUND

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

  PMID: 29985182 BACKGROUND

• 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.

  PMID: 31506779 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc. Prof., MD, PhD

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 31, 2025
• Study Start: August 25, 2021
• Primary Completion: August 28, 2022
• Study Completion: September 1, 2022
• Last Updated: March 31, 2025

Record last verified: 2025-03

Locations

TU (1)