- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06855199
CAUDAL EPIDURAL BLOCK in PEDIATRIC SURGERY CASES
February 26, 2025 updated by: Cigdem Demirci
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.
Study Overview
Status
Recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
55
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: çiğdem demirci
- Phone Number: 05414104211
- Email: cigdem_cirik@hotmail.com
Study Locations
-
-
-
Sivas, Turkey
- Recruiting
- Sivas State Hospital
-
Contact:
- çiğdem demirci
- Phone Number: 05414104211
- Email: cigdem_cirik@hotmail.com
-
Contact:
- çiğdem demirci
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
PEDIATRIC GROUP BETWEEN 1-6 YEARS
Description
Inclusion Criteria:
- lower abdominal/urogenital/lower extremity surgery
- Patients with ASA1-2
Exclusion Criteria:
- Those with neuromuscular disease
- PATIENTS WITH ASA3-4
- patients with cerebral palsy
- patients in mental reter
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
After the caudal block is performed, it will be monitored for 20 minutes.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 10, 2024
Primary Completion (Actual)
November 10, 2024
Study Completion (Estimated)
June 30, 2025
Study Registration Dates
First Submitted
November 28, 2024
First Submitted That Met QC Criteria
February 26, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 26, 2025
Last Verified
November 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SDH-AR-CD-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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