NCT06855199

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2024

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 3, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

March 3, 2025

Status Verified

November 1, 2024

Enrollment Period

Same day

First QC Date

November 28, 2024

Last Update Submit

February 26, 2025

Conditions

Keywords

GALVANİC SKİN RESPONSEPEDIATRIC PATIENT

Outcome Measures

Primary Outcomes (1)

  • Evaluation of block success in patients undergoing caudal epidural block

    Evaluation of block success in patients undergoing caudal epidural block

    After the caudal block is performed, it will be monitored for 20 minutes.

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

PEDIATRIC GROUP BETWEEN 1-6 YEARS

You may qualify if:

  • lower abdominal/urogenital/lower extremity surgery
  • Patients with ASA1-2

You may not qualify if:

  • Those with neuromuscular disease
  • PATIENTS WITH ASA3-4
  • patients with cerebral palsy
  • patients in mental reter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sivas State Hospital

Sivas, Sivas, Turkey (Türkiye)

RECRUITING

Central Study Contacts

ÇİĞDEM DEMİRCİ

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

November 28, 2024

First Posted

March 3, 2025

Study Start

November 10, 2024

Primary Completion

November 10, 2024

Study Completion

June 30, 2025

Last Updated

March 3, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations