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

NCT ID: NCT04861935

Last Updated: 2023-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-11
• Study Completion Date: 2023-02-11

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.

Detailed Description

A dimple over the sacrum may be an isolated finding or a sign of underlying spinal abnormality. Therefore, most practitioners are confused to perform a caudal block. Ultrasonography is a safe and cost effective screening tool in pediatric patients. Ultrasound guided investigation of the anatomical features of sacral region may play a key role to eliminate suspicions. It is possible to detect spinal abnormalities and also measuring dural sac level, distance between dural sac and estimated needle insertion site or needle entry angle. In this study, we will examine whether there is a difference between normal children and children with dimple in the sacral region.

Conditions

Sacrococcygeal Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ultrasound evaluation of sacral region in normal pediatric patients

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.

Group Type: PLACEBO_COMPARATOR

ultrasound evaluation

Intervention Type: DEVICE

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

ultrasound evaluation of sacral region in patients with sacral dimple

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.

Group Type: ACTIVE_COMPARATOR

ultrasound evaluation

Intervention Type: DEVICE

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

Interventions

ultrasound evaluation

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 72 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Celal Kaya

Principal Investigator, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guner Kaya, Prof.

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Locations

Istanbul University Cerrahpasa

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 21981093 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29963103 (View on PubMed)

Other Identifiers

72109855-604.01.01-231115

Identifier Type: -

Identifier Source: org_study_id