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

Ultrasound-Guided Low-dose Caudal Epidural Block Versus Ultrasound-Guided Pudendal Nerve Block for Pediatric Circumcision: A Prospective Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04268511
Enrollment
100
Registered
2020-02-13
Start date
2019-08-01
Completion date
2019-12-20
Last updated
2020-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circumcision

Keywords

Ultrasound, Pudendal nerve block, Caudal epidural block, Pain

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.

Interventions

PROCEDURECaudal 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

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.

Sponsors

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Time of Postoperative analgesic requirementUp to 12 hoursIt was assessed five times after the operation with Children's Hospital Eastern Ontario Pain Scale. The lowest scale score is 4 points and the highest 13 points. Significant pain behavior for Children's Hospital Eastern Ontario Pain Scale has been identified as 7 points or more. Following transfer from the recovery unit to the ward, the 30 minutes, 1st, 2nd, 6th, and 12th hour pain levels were evaluated by the ward nurse.
Level of Postoperative painUp to 12 hoursIt was assessed five times after the operation with Children's Hospital Eastern Ontario Pain Scale. The lowest scale score is 4 points and the highest 13 points. Significant pain behavior for Children's Hospital Eastern Ontario Pain Scale has been identified as 7 points or more. Following transfer from the recovery unit to the ward, the 30 minutes, 1st, 2nd, 6th, and 12th hour pain levels were evaluated by the ward nurse.

Secondary

MeasureTime frameDescription
Rate of Postoperative complicationsUp to 12 hoursUrinary retention, nausea, vomiting, lower extremity numbness, motor block were postoperative complications. They were assessed by ward nurse.
Level of Parent satisfactionUp to 24 hoursThe parents were asked about their satisfaction with the child's comfort and activity level \[1, unsatisfied; 2, satisfied (good); 3, absolutely satisfied (excellent)\] at the 24-hour follow-up

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026