Clinical trial NCT05708989: Caudal vs. Pudendal Block in Peds GU
Official title: Caudal vs. Pudendal Block for Early Postoperative Pain Control in a Pediatric Population Undergoing Lower Genitourinary Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Hypospadias
Penile Torsion
Chordee
Phimosis
Keywords: caudal block
pudendal block
regional anesthesia
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 0
Sex: MALE
Minimum age (years): 6
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare two techniques to minimize pain during and after penile surgery in children undergoing certain urologic surgeries. These two approaches include the caudal nerve block and the pudendal nerve block.


Eligibility criteria: Inclusion Criteria:

* Undergoing penile genitourinary surgery
* ASA class 1-3

Exclusion Criteria:

* Female patients
* Male children \<6 months or \>/= 3 years of age
* ASA class \>3
* Surgery at satellite location (non-Prentiss)
* Concurrent non-lower GU tract surgery
* Sacrospinal abnormality
* History of chronic pain requiring opioid analgesics
* Inability to tolerate and receive acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), alpha-2 agonists, or local anesthetics
* History of malignant hyperthermia
* History of coagulopathy

Primary outcomes:
measure: Rescue Narcotic Administration
timeFrame: During post-operative in-hospital recovery, approximately 1 hour
Secondary outcomes:
measure: Non-Narcotic Rescue Administration at 24 hours
timeFrame: During first day after surgery, approximately 24 hours
measure: Non-Narcotic Rescue Administration at 48 hours
timeFrame: During second day after surgery, approximately 48 hours
measure: Non-Narcotic Rescue Administration at 72 hours
timeFrame: During third day after surgery, approximately 72 hours
measure: Number of participants with at least one adverse event (AE) as measured by patient report
timeFrame: End of study, up to 3 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: UH Rainbow Babies and Children's Hospital
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Jessica H Hannick, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wren AA, Ross AC, D'Souza G, Almgren C, Feinstein A, Marshall A, Golianu B. Multidisciplinary Pain Management for Pediatric Patients with Acute and Chronic Pain: A Foundational Treatment Approach When Prescribing Opioids. Children (Basel). 2019 Feb 21;6(2):33. doi: 10.3390/children6020033.
citation: Vargas A, Sawardekar A, Suresh S. Updates on pediatric regional anesthesia safety data. Curr Opin Anaesthesiol. 2019 Oct;32(5):649-652. doi: 10.1097/ACO.0000000000000768.
citation: Wiegele M, Marhofer P, Lonnqvist PA. Caudal epidural blocks in paediatric patients: a review and practical considerations. Br J Anaesth. 2019 Apr;122(4):509-517. doi: 10.1016/j.bja.2018.11.030. Epub 2019 Feb 1.
citation: Okoro C, Huang H, Cannon S, Low D, Liston DE, Richards MJ, Lendvay TS. The pudendal nerve block for ambulatory urology: What's old is new again. A quality improvement project. J Pediatr Urol. 2020 Oct;16(5):594.e1-594.e7. doi: 10.1016/j.jpurol.2020.07.025. Epub 2020 Jul 24.
citation: Shah UJ, Nguyen D, Karuppiaah N, Martin J, Sehmbi H. Efficacy and safety of caudal dexmedetomidine in pediatric infra-umbilical surgery: a meta-analysis and trial-sequential analysis of randomized controlled trials. Reg Anesth Pain Med. 2021 May;46(5):422-432. doi: 10.1136/rapm-2020-102024. Epub 2021 Jan 15.
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.
citation: Naja ZM, Ziade FM, Kamel R, El-Kayali S, Daoud N, El-Rajab MA. The effectiveness of pudendal nerve block versus caudal block anesthesia for hypospadias in children. Anesth Analg. 2013 Dec;117(6):1401-7. doi: 10.1213/ANE.0b013e3182a8ee52.