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NCT Number: NCT06855199

CAUDAL EPIDURAL BLOCK IN PEDIATRIC SURGERY CASES

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.

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Key information

Conditions

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sivas State Hospital

Sivas, Turkey (Türkiye)

Location status: Recruiting

Location contact

çiğdem demirci

CONTACT

[email protected]

05414104211

çiğdem demirci

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

ÇİĞDEM DEMİRCİ

CONTACT

[email protected]

05414104211

Sponsors and collaborators

Lead sponsor

Cigdem Demirci

Other

Collaborators

  • Adiyaman University Research Hospital
  • sivas devlet hastanesi

Registry information

Official study title

INVESTIGATION OF THE CORRELATION OF BLOCK SUCCESS WITH GALVANIC SKIN RESPONSE IN PEDIATRIC SURGERY CASES PERFORMED UNDER CAUDAL EPIDURAL BLOCK ANESTHESIA

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Mar 3, 2025
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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