Caudal vs. Pudendal Block in Peds GU

Hypospadias Clinical Trial

Official title:

Caudal vs. Pudendal Block for Early Postoperative Pain Control in a Pediatric Population Undergoing Lower Genitourinary Surgery

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05708989
• Other study ID #: STUDY20220033
• Status: Suspended
• Phase: Phase 4
• Start date: March 6, 2023
• Est. completion date: May 2025

Study information

• Verified date: August 2023
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 138
• Est. completion date: May 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Months to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Chordee
• Hypospadias
• Phimosis

Intervention

Procedure:
• Caudal Block
Injectable 1 ml/kg of 0.25% ropivacaine with 1mcg/kg dexmedetomidine into caudal spinal space. First attempt will be landmark-guided into the caudal spine region. Subsequent attempt(s) may be done using ultrasound.
• Ultrasound-guided Pudendal Block
Injection of 0.5 ml/kg per side of injectable 0.2-0.3% ropivacaine with 0.5 mcg/kg dexmetomedine. Ultrasound-guided injection into each pudendal nerve region through skin of buttocks.

Drug:
• Injectable 1 ml/kg of 0.25% ropivacaine with 1mcg/kg dexmedetomidine
Injectable 1 ml/kg of 0.25% ropivacaine with 1mcg/kg dexmedetomidine into caudal spinal space. First attempt will be landmark-guided into the caudal spine region. Subsequent attempt(s) may be done using ultrasound.
• Injection of 0.5 ml/kg per side of injectable 0.2-0.3% ropivacaine with 0.5 mcg/kg dexmetomedine.
Injection of 0.5 ml/kg per side of injectable 0.2-0.3% ropivacaine with 0.5 mcg/kg dexmetomedine. Ultrasound-guided injection into each pudendal nerve region through skin of buttocks.

Locations

Country	Name	City	State
United States	UH Rainbow Babies and Children's Hospital	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rescue Narcotic Administration	Dose (mg) of postoperative rescue opioid	During post-operative in-hospital recovery, approximately 1 hour
Secondary	Non-Narcotic Rescue Administration at 24 hours	Dose (mg) of non-narcotic rescue medication	During first day after surgery, approximately 24 hours
Secondary	Non-Narcotic Rescue Administration at 48 hours	Dose (mg) of non-narcotic rescue medication	During second day after surgery, approximately 48 hours
Secondary	Non-Narcotic Rescue Administration at 72 hours	Dose (mg) of non-narcotic rescue medication	During third day after surgery, approximately 72 hours
Secondary	Number of participants with at least one adverse event (AE) as measured by patient report	Adverse events will include any AE related to study procedure	End of study, up to 3 months