Hydrocephalus in ChildrenNCT06903598
Scalp Blocks for Pediatric External Ventricular Drainage Placement
An observational study of Hydrocephalus in Children and Regional Block, run by Hande Gurbuz at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Hydrocephalus in Children, Regional Block, Pediatric Anesthesia
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2021to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children under 18 undergoing external ventricular drainage placement in the operating room between 2021 and 2022 in Bursa Yuksek Ihtisas TRH.
Who may be able to join
- Children undergoing external ventricular drainage
Who cannot join
- Children who were intubated preoperatively.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, Yildirim
About this study
Official title: 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Scalp Block | Those who underwent surgery with scalp block | |
| Local infiltration | Those who underwent surgery with local anesthetic infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthesia method
The anesthesia method used for the surgery (general anesthesia or sedation)
Measured: From enrollment to the end of surgery
Secondary outcomes (1)
Analgesic consumption
Total analgesic consumption within the first 24 in the postoperative period.
Measured: Postoperative first 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2025
- Study start25 Aug 2021
- Primary completion28 Aug 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hydrocephalus in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hande Gurbuz
- Sponsor type
- Other government
- Collaborators
- Bursa Yuksek Ihtisas Training and Research Hospital
- Responsible party
- Sponsor-investigator, Hande Gurbuz, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903598
- Sponsor's protocol ID
- 2011-KAEK-25 2021/08-24
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 31 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data sets used in this research may be made available upon reasonable request to the corresponding author.
Publications
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.
PubMed 31879855Carella 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.
PubMed 33060491Lamsal R, Rath GP. Pediatric neuroanesthesia. Curr Opin Anaesthesiol. 2018 Oct;31(5):539-543. doi: 10.1097/ACO.0000000000000630.
PubMed 29985182van 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.
PubMed 31506779
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesia and Analgesia Methods in Pediatric External Ventricular Drainage Placement
- ClinicalTrials.gov ID
- NCT06903598
- Acronym / sponsor ID
- 2011-KAEK-25 2021/08-24
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Hande GurbuzOther government
- Collaborators
- Bursa Yuksek Ihtisas Training and Research Hospital
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 28 Aug 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 31 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scalp Block | – | –Those who underwent surgery with scalp block |
| Local infiltration | – | –Those who underwent surgery with local anesthetic infiltration |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children under 18 undergoing external ventricular drainage placement in the operating room between 2021 and 2022 in Bursa Yuksek Ihtisas TRH.
Key inclusion criteria (1 listed)
- Children undergoing external ventricular drainage
Key exclusion criteria (1 listed)
- Children who were intubated preoperatively.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anesthesia method
Time frame: From enrollment to the end of surgery
The anesthesia method used for the surgery (general anesthesia or sedation)
1 secondary outcome
Analgesic consumption
Time frame: Postoperative first 24 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2025.
- Background: PubMed 31879855Rigamonti 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.
- Background: PubMed 33060491Carella 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.
- Background: PubMed 29985182Lamsal R, Rath GP. Pediatric neuroanesthesia. Curr Opin Anaesthesiol. 2018 Oct;31(5):539-543. doi: 10.1097/ACO.0000000000000630.
- Background: PubMed 31506779van 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.
- Individual participant dataSharing planned: Undecided. The data sets used in this research may be made available upon reasonable request to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrocephalus in Children and Regional Block, run by Hande Gurbuz at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anesthesia method (time frame: From enrollment to the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06903598, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2025.