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

Completed

• Conditions: Circumcision
• Interventions: Procedure: Pudendal nerve block group; Procedure: Caudal epidural block group

• Registration Number: NCT04268511
• Lead Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

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.

Study Timeline

• Study Start: 2019-08-01
• Primary Completion: 2019-10-01
• Study Completion: 2019-12-20
• Study First Submitted: 2020-02-11
• Study First Submitted QC: 2020-02-11
• Study First Posted: 2020-02-13
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-10
• Last Update Posted: 2020-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pudendal nerve block group	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.
Caudal epidural block group	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.

Primary Outcome Measures

Name	Time	Method
Time of Postoperative analgesic requirement	Up to 12 hours	It 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 pain	At the 24th hour	It was assessed one time for 24th hour by parents with Faces Pain Scale-Revised. The scale is scored in even numbers from 0 to 10, which themselves indicate no pain and significant pain, respectively. The parents were also informed that a scale score of 4 or more

Secondary Outcome Measures

Name	Time	Method
Rate of Postoperative complications	Up to 12 hours	Urinary retention, nausea, vomiting, lower extremity numbness, motor block were postoperative complications. They were assessed by ward nurse.
Level of Parent satisfaction	Up to 24 hours	The 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

Trial Locations

Locations (1)

Okmeydani Training and Research Hospital; 🇹🇷 Istanbul, Şişli, Turkey