Clinical trial NCT04268511: Caudal Epidural Block Versus Ultrasound-Guided Pudendal Nerve Block for Pediatric Circumcision
Official title: Ultrasound-Guided Low-dose Caudal Epidural Block Versus Ultrasound-Guided Pudendal Nerve Block for Pediatric Circumcision: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Circumcision
Keywords: Ultrasound
Pudendal nerve block
Caudal epidural block
Pain
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.

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.

Primary outcomes:
measure: Time of Postoperative analgesic requirement
timeFrame: Up to 12 hours
measure: Level of Postoperative pain
timeFrame: Up to 12 hours
measure: Level of Postoperative pain
timeFrame: At the 24th hour
Secondary outcomes:
measure: Rate of Postoperative complications
timeFrame: Up to 12 hours
measure: Level of Parent satisfaction
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Okmeydani Training and Research Hospital
state: Şişli
Study officials:
affiliation: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
name: Volkan Ozen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.