Out Of-plane Technique Against In-plane for Caudal Block

NCT04671992 | Unknown

• 1 other identifier: farukcicekci3
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Caudal block is an easy and effective type of central neuraxial block that is widely used in subumbilical surgeries to provide intraoperative and postoperative analgesia in the pediatric population. Caudal block application with ultrasound (USG) was first applied in 2003. Sacrum, sacral cornular, sacrococcygeal ligament and sacral hiatus can be easily distinguished by ultrasound. The probe is positioned in a horizontal midline position on the lower sacrum. Sacral roots within the caudal epidural space can be seen as hypoechoic ellipses. In addition, anatomical variations of the sacral hiatus and the process area can be clearly observed. A accurate probe use with ultrasound guided is confirmed by advancing the caudal needle in the desired direction, widening in the sacral hiatus with local anesthetic injection, and the turbulence observed during injection into the sacral canal if the color doppler feature is used. Thus, a decrease in complications and an increase in the success of the procedure can be achieved with simultaneous imaging. In addition, in cases where the block is difficult, the in-plane technique can be preferred in the midline plane.The aim of this study is to compare the success rates and postoperative pain levels of caudal block applications with the out of plane technique (probe applied by holding horizontal) and in-plane technique (probe applied vertically), which is routinely applied with ultrasound in pediatric hypospadias surgery.

Conditions

Ultrasound Imaging; Caudal Block; Hypospadias

Outcome Measures

Primary Outcomes (1)

• the success rates of in-plane and out of-plane techniques

  To measure success rates of in-plane and out-of-plane techniques for caudal block, the number of successful processing and the time of processing (minute) will be used

  4 months

Secondary Outcomes (1)

• The postoperative pain levels

  4 months

Study Arms (2)

Ultrasound Guided Out of-Plane Technique

ACTIVE COMPARATOR

Ultrasound Guided Out of plane technique (probe applied by holding horizontal)

Device: Out of-Plane Technique and In-Plane on

Ultrasound Guided In-Plane Technique

ACTIVE COMPARATOR

Ultrasound Guided Out of plane technique (probe applied by holding vbertical)

Device: Out of-Plane Technique and In-Plane on

Interventions

Out of-Plane Technique and In-Plane on DEVICE

A comparison of out of-plane technique and in-plane

Ultrasound Guided In-Plane Technique; Ultrasound Guided Out of-Plane Technique

Eligibility Criteria

• Age: 6 Months - 10 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients undergoing hypospadias surgery
• ASA PS I-II group

You may not qualify if:

• Previous neurological or spinal disorder,
• Coagulation anomaly
• Allergy to local anesthetics
• Local infection in the block area
• Children with a history of preterm birth

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University, School of Medicine

Konya, 42080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypospadias

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 6, 2020
• First Posted: December 17, 2020
• Study Start: December 1, 2020
• Primary Completion: March 31, 2021
• Study Completion: April 15, 2021
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)