Pediatric PatientNCT06855199
CAUDAL EPIDURAL BLOCK IN PEDIATRIC SURGERY CASES
An observational study of Pediatric Patient, run by Cigdem Demirci at 1 site in Turkey (Türkiye).
Trial summary
Caudal epidural anesthesia was reported as the first epidural anesthesia technique in 1933, but its use began to become widespread after the 1960s (1). The procedure is reliable, easy to perform, the incidence of complications is low, and the total complication rate is 1.5/1000; Serious complications occur at a rate… Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Pediatric Patient
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Nov 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 year to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: PEDIATRIC GROUP BETWEEN 1-6 YEARS
Who may be able to join
- lower abdominal/urogenital/lower extremity surgery
- Patients with ASA1-2
Who cannot join
- Those with neuromuscular disease
- PATIENTS WITH ASA3-4
- patients with cerebral palsy
- patients in mental reter
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sivas State Hospital
Sivas, Sivas
çiğdem demirci, 05414104211, cigdem_cirik@hotmail.com
çiğdem demirci
About this study
Official title: INVESTIGATION OF THE CORRELATION OF BLOCK SUCCESS WITH GALVANIC SKIN RESPONSE IN PEDIATRIC SURGERY CASES PERFORMED UNDER CAUDAL EPIDURAL BLOCK ANESTHESIA
Caudal epidural anesthesia was reported as the first epidural anesthesia technique in 1933, but its use began to become widespread after the 1960s (1). The procedure is reliable, easy to perform, the incidence of complications is low, and the total complication rate is 1.5/1000; Serious complications occur at a rate of 1/40000. There are many methods to demonstrate the success of caudal epidural block. Some of the common traditional methods are changes in mean arterial pressure and heart rate. These methods are sometimes not objective and take time. In this study, we will examine the block success in pediatric patients who underwent caudal epidural block, which is applied in our hospital, whether the Galvanic skin response measured with a finger probe, other than traditional methods, correlates with the block success, and whether it shows faster block success compared to other traditional methods.
Read the detailed description
A successful caudal epidural block can provide safe, effective regional anesthesia. (4). The overall failure rate of caudal epidural block in pediatric patients is approximately 4%, depending on the anatomical and developmental abnormalities of the caudal canal (5,6). Therefore, reliable and rapid evaluation of a successful caudal epidural block is important to optimize anesthesia management in pediatric patients. Evaluating the success of caudal epidural block with traditional methods such as mean arterial pressure (MAP) and heart rate (HR) does not give completely objective results and takes time. Galvanic Skin Response (GSR) is a parameter that shows sweat gland function related to the autonomic nervous system. Physically, the galvanic skin response is the change in the electrical structure of the skin in response to various stimuli (7).Changes in tension measured from the skin surface are recorded. The relaxation and calming response accompanies an increase in skin resistance, while the fight response accompanies a decrease in skin resistance. In general, low conductivity is a sign of relaxation. High conductivity is a sign of emotional, mental or physical arousal (8). Galvanic Skin Response (GSR) evaluation is a non-invasive measurement that allows us to observe skin resistance changes with two probes attached to the fingertip. The aim of this study is to evaluate whether using Galvanic skin response (GSR) values measured with a finger probe will detect the success of caudal epidural block more quickly than other traditional methods in pediatric patients who underwent surgery with caudal epidural block.
- Conditions
- Pediatric Patient
- Keywords
- GALVANİC SKİN RESPONSE, PEDIATRIC PATIENT
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of block success in patients undergoing caudal epidural block
Evaluation of block success in patients undergoing caudal epidural block
Measured: After the caudal block is performed, it will be monitored for 20 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start10 Nov 2024
- Primary completion10 Nov 2024
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric PatientStudies 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
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cigdem Demirci
- Sponsor type
- University, hospital or other
- Collaborators
- sivas devlet hastanesi, Adiyaman University Research Hospital
- Responsible party
- Sponsor-investigator, Cigdem Demirci, sivas devlet hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855199
- Sponsor's protocol ID
- SDH-AR-CD-01
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2024
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INVESTIGATION OF THE CORRELATION OF BLOCK SUCCESS WITH GALVANIC SKIN RESPONSE IN PEDIATRIC SURGERY CASES PERFORMED UNDER CAUDAL EPIDURAL BLOCK ANESTHESIA
- ClinicalTrials.gov ID
- NCT06855199
- Acronym / sponsor ID
- SDH-AR-CD-01
- Conditions
- Pediatric Patient
- Keywords
- GALVANİC SKİN RESPONSE, PEDIATRIC PATIENT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Cigdem DemirciUniversity, hospital or other
- Collaborators
- sivas devlet hastanesi, Adiyaman University Research Hospital
- Study start
- 10 Nov 2024 (actual)
- Primary completion
- 10 Nov 2024 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 3 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.
Caudal epidural anesthesia was reported as the first epidural anesthesia technique in 1933, but its use began to become widespread after the 1960s (1). The procedure is reliable, easy to perform, the incidence of complications is low, and the total complication rate is 1.5/1000; Serious complications occur at a rate of 1/40000. There are many methods to demonstrate the success of caudal epidural block. Some of the common traditional methods are changes in mean arterial pressure and heart rate. These methods are sometimes not objective and take time. In this study, we will examine the block success in pediatric patients who underwent caudal epidural block, which is applied in our hospital, whether the Galvanic skin response measured with a finger probe, other than traditional methods, correlates with the block success, and whether it shows faster block success compared to other traditional methods.
Detailed description
A successful caudal epidural block can provide safe, effective regional anesthesia. (4). The overall failure rate of caudal epidural block in pediatric patients is approximately 4%, depending on the anatomical and developmental abnormalities of the caudal canal (5,6). Therefore, reliable and rapid evaluation of a successful caudal epidural block is important to optimize anesthesia management in pediatric patients. Evaluating the success of caudal epidural block with traditional methods such as mean arterial pressure (MAP) and heart rate (HR) does not give completely objective results and takes time. Galvanic Skin Response (GSR) is a parameter that shows sweat gland function related to the autonomic nervous system. Physically, the galvanic skin response is the change in the electrical structure of the skin in response to various stimuli (7).Changes in tension measured from the skin surface are recorded. The relaxation and calming response accompanies an increase in skin resistance, while the fight response accompanies a decrease in skin resistance. In general, low conductivity is a sign of relaxation. High conductivity is a sign of emotional, mental or physical arousal (8). Galvanic Skin Response (GSR) evaluation is a non-invasive measurement that allows us to observe skin resistance changes with two probes attached to the fingertip. The aim of this study is to evaluate whether using Galvanic skin response (GSR) values measured with a finger probe will detect the success of caudal epidural block more quickly than other traditional methods in pediatric patients who underwent surgery with caudal epidural block.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- PEDIATRIC GROUP BETWEEN 1-6 YEARS
Key inclusion criteria (2 listed)
- lower abdominal/urogenital/lower extremity surgery
- Patients with ASA1-2
Key exclusion criteria (4 listed)
- Those with neuromuscular disease
- PATIENTS WITH ASA3-4
- patients with cerebral palsy
- patients in mental reter
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
Evaluation of block success in patients undergoing caudal epidural block
Time frame: After the caudal block is performed, it will be monitored for 20 minutes.
Evaluation of block success in patients undergoing caudal epidural block
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: No
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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.
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 Pediatric Patient, run by Cigdem Demirci 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ÇİĞDEM DEMİRCİ (05414104211, cigdem_cirik@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of block success in patients undergoing caudal epidural block (time frame: After the caudal block is performed, it will be monitored for 20 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2025.