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

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.

Study Overview

• Status: Completed
• Conditions: Circumcision
• Intervention / Treatment: Procedure: Caudal epidural block group; Procedure: Pudendal nerve block group

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Turkey
  • Şişli
    • Istanbul, Şişli, Turkey, 34384
      • Okmeydani Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Male patients aged between 4-12 years in the ASA (American Society of Anesthesiologists) I-II group and scheduled for circumcision

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: 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
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of Postoperative analgesic requirement	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.	Up to 12 hours
Level of Postoperative pain	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.	Up to 12 hours
Level of Postoperative pain	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	At the 24th hour

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
• Investigators: Principal Investigator: Volkan Ozen, MD, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): December 20, 2019

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 11, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Actual): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Ultrasound; Pain; Pudendal nerve block; Caudal epidural block
• Other Study ID Numbers: 1374

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No