Ultrasound Guided Investigation Of The Anatomical Features For Caudal Block In Children With Sacral Dimple

NCT04861935 | Completed

• 1 other identifier: 72109855-604.01.01-231115
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

When dimples are detected in the sacral region, most practitioners consider it to be a sign of spinal anomaly and avoid caudal block. Ultrasound guided investigation of the anatomical features for caudal block in normal children and in children with sacral dimple will be informative for practitioners.

Conditions

Sacrococcygeal Disorder

Keywords

pediatric, sacral dimple, ultrasound

Outcome Measures

Primary Outcomes (3)

• ultrasound measurement-1

  Dural sac level (mm)

  1 min

• ultrasound measurement-2

  distance between injection site and dural sac(mm)

  1 min

• ultrasound measurement-3

  optimal entry angle (0-angle degree) for caudal block

  1 min

Secondary Outcomes (1)

• ultrasound evaluation of sacral region

  10 minutes

Study Arms (2)

ultrasound evaluation of sacral region in normal pediatric patients

PLACEBO COMPARATOR

Ultrasound evaluation of sacral region will be performed to detect spinal abnormality. Dural sac level and its distance to estmated injection site, optimal entry angle for caudal block will be measured.

Device: ultrasound evaluation

ultrasound evaluation of sacral region in patients with sacral dimple

ACTIVE COMPARATOR

Ultrasound evaluation of sacral region will be performed to detect spinal abnormality. Dural sac level and its distance to estmated injection site, optimal entry angle for caudal block will be measured.

Device: ultrasound evaluation

Interventions

ultrasound evaluation DEVICE

ultrasound evaluation of normal patients and patients who have a sacral dimple

ultrasound evaluation of sacral region in normal pediatric patients; ultrasound evaluation of sacral region in patients with sacral dimple

Eligibility Criteria

• Age: 1 Month - 72 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 1-72 months who are taken to the operating room for any reason

You may not qualify if:

• spinal anomalies,
• history of prematurity,
• neurological disorder
• syndromic illness.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Cerrahpasa

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (2)

• Schwartz D, Al-Najjar H, Connelly NR. Caudal block in a child with a sacral dimple utilizing ultrasonography. Paediatr Anaesth. 2011 Oct;21(10):1073-4. doi: 10.1111/j.1460-9592.2011.03621.x. No abstract available.

  PMID: 21981093 BACKGROUND

• Choi JH, Lee T, Kwon HH, You SK, Kang JW. Outcome of ultrasonographic imaging in infants with sacral dimple. Korean J Pediatr. 2018 Jun;61(6):194-199. doi: 10.3345/kjp.2018.61.6.194. Epub 2018 Jun 25.

  PMID: 29963103 BACKGROUND

Study Officials

• Guner Kaya, Prof.

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD

Model Details: Two groups were formed as those with and without dimples in the sacral region.

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 27, 2021
• Study Start: November 11, 2022
• Primary Completion: February 11, 2023
• Study Completion: February 11, 2023
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)