Clinical trial NCT06903598: Scalp Blocks for Pediatric External Ventricular Drainage Placement
Official title: Anesthesia and Analgesia Methods in Pediatric External Ventricular Drainage Placement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hydrocephalus in Children
Regional Block
Pediatric Anesthesia
Lead sponsor: Bursa City Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Bursa Yüksek İhtisas Education and Research Hospital
First posted: 2025-03-31
Enrollment: 63
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* Children undergoing external ventricular drainage

Exclusion Criteria:

* Children who were intubated preoperatively.

Primary outcomes:
measure: Anesthesia method
timeFrame: From enrollment to the end of surgery
Secondary outcomes:
measure: Analgesic consumption
timeFrame: Postoperative first 24 hours.
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
state: Yildirim
Study officials:
References:
citation: 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.
citation: 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.
citation: Lamsal R, Rath GP. Pediatric neuroanesthesia. Curr Opin Anaesthesiol. 2018 Oct;31(5):539-543. doi: 10.1097/ACO.0000000000000630.
citation: 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.