Caudal Epidural Block Versus Ultrasound-Guided Pudendal Nerve Block for Pediatric Circumcision

NCT ID: NCT04268511

Last Updated: 2020-08-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2019-12-20

Brief Summary

The regional anesthesia methods of caudal epidural block (CEB) and dorsal penile nerve block (DPNB) play an important role in providing postoperative pain control in pediatric circumcision surgery. However, the short-term postoperative analgesic effect and the risk of block failure limit the use of DPNB, a peripheral nerve block.

Detailed Description

CEB is a neuraxial block and commonly used to control moderate and severe postoperative pain following surgery related to the lumbosacral and midthoracic dermatomes. CEB can have serious undesirable complications such as intravascular and subarachnoid injection, urinary retention and motor block. Pudendal nerve block can be used as an alternative to both DPNB and CEB for penile surgery such as circumcision. The pudendal nerve is a peripheral nerve combining the anterior rami of the sacral plexus nerves (S2-S4) and provides motor and sensory innervation to the perineal region.

Conditions

Circumcision

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Caudal epidural block group

Linear ultrasound probe and the sacral hiatus at the sacral cornu level was visualized using an out-of-plane transverse view at 5-10 megahertz . The linear probe was then rotated 90 degrees and placed longitudinally in the midline to evaluate the sacral cornus, sacrococcygeal ligament and sacral bone.

Caudal epidural block group

Intervention Type: PROCEDURE

The linear probe of ultrasound was then rotated 90 degrees and placed longitudinally in the midline to evaluate the sacral cornus, sacrococcygeal ligament and sacral bone. A 22 Gauge 50 mm echogenic block needle was advanced

Pudendal nerve block group

The long axis of the ultrasound probe was positioned on a horizontal line connecting the ischial tuberosity that had been previously located by palpation to the anus. The ischial tuberosity could be easily identified as a hypoechoic area that is bounded superiorly by a hyperechoic line. The probe was then moved medially on the same axis until the rectum appeared as another hypoechoic area.

Pudendal nerve block group

Intervention Type: PROCEDURE

A 22 Gauge 50 mm insulated needle was then introduced in the anterior-posterior direction at the middle of the ultrasound probe's superior edge with an out-of-plane approach and using an inclination of 15° in the sagittal plane. The needle tip's position was identified by direct visualization using the movement of adjacent anatomical structures.

Interventions

Caudal epidural block group

The linear probe of ultrasound was then rotated 90 degrees and placed longitudinally in the midline to evaluate the sacral cornus, sacrococcygeal ligament and sacral bone. A 22 Gauge 50 mm echogenic block needle was advanced

Intervention Type: PROCEDURE

Pudendal nerve block group

A 22 Gauge 50 mm insulated needle was then introduced in the anterior-posterior direction at the middle of the ultrasound probe's superior edge with an out-of-plane approach and using an inclination of 15° in the sagittal plane. The needle tip's position was identified by direct visualization using the movement of adjacent anatomical structures.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Male patients aged between 4-12 years
• ASA (American Society of Anesthesiologists) I-II group
• Scheduled for circumcision
• Able to communicate in Turkish
• Willing to participate to the study (parents and children)

Exclusion Criteria

• Patients aged less than 4 or more than 12 years
• Neurological deficit
• Bleeding diathesis
• History of local anesthetic allergy
• Current infection or redness in the region to be injected
• Congenital lower back anomaly
• Liver disease
• Psychiatric disorder
• Mental retardation
• Communication problem
• Refusal to participate in the study.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

OTHER

Sponsor Role: lead

Responsible Party

Volkan Ozen

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Volkan Ozen, MD

Role: PRINCIPAL_INVESTIGATOR

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Locations

Okmeydani Training and Research Hospital

Istanbul, Şişli, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Tutuncu AC, Kendigelen P, Ashyyeralyeva G, Altintas F, Emre S, Ozcan R, Kaya G. Pudendal Nerve Block Versus Penile Nerve Block in Children Undergoing Circumcision. Urol J. 2018 May 3;15(3):109-115. doi: 10.22037/uj.v0i0.4292.

Reference Type: BACKGROUND

PMID: 29299888 (View on PubMed)

Gaudet-Ferrand I, De La Arena P, Bringuier S, Raux O, Hertz L, Kalfa N, Sola C, Dadure C. Ultrasound-guided pudendal nerve block in children: A new technique of ultrasound-guided transperineal approach. Paediatr Anaesth. 2018 Jan;28(1):53-58. doi: 10.1111/pan.13286. Epub 2017 Dec 5.

Reference Type: BACKGROUND

PMID: 29205687 (View on PubMed)

Kendigelen P, Tutuncu AC, Emre S, Altindas F, Kaya G. Pudendal Versus Caudal Block in Children Undergoing Hypospadias Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):610-5. doi: 10.1097/AAP.0000000000000447.

Reference Type: BACKGROUND

PMID: 27501015 (View on PubMed)

Other Identifiers

1374

Identifier Type: -

Identifier Source: org_study_id