Caudal vs. Pudendal Block in Peds GU

NCT05708989 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: STUDY20220033
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypospadias; Penile Torsion; Chordee; Phimosis

Keywords

caudal block; pudendal block; regional anesthesia

Outcome Measures

Primary Outcomes (1)

• Rescue Narcotic Administration

  Dose (mg) of postoperative rescue opioid

  During post-operative in-hospital recovery, approximately 1 hour

Secondary Outcomes (4)

• Non-Narcotic Rescue Administration at 24 hours

  During first day after surgery, approximately 24 hours

• Non-Narcotic Rescue Administration at 48 hours

  During second day after surgery, approximately 48 hours

• Non-Narcotic Rescue Administration at 72 hours

  During third day after surgery, approximately 72 hours

• Number of participants with at least one adverse event (AE) as measured by patient report

  End of study, up to 3 months

Study Arms (2)

Caudal Block

ACTIVE COMPARATOR

Patients will receive a caudal block prior to surgery.

Procedure: Caudal Block; Drug: Injectable 1 ml/kg of 0.25% ropivacaine with 1mcg/kg dexmedetomidine

Pudendal Block

EXPERIMENTAL

Patients will receive a pudendal block prior to surgery.

Procedure: Ultrasound-guided Pudendal Block; Drug: Injection of 0.5 ml/kg per side of injectable 0.2-0.3% ropivacaine with 0.5 mcg/kg dexmetomedine.

Interventions

Caudal Block PROCEDURE

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.

Caudal Block

Ultrasound-guided Pudendal Block PROCEDURE

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.

Pudendal Block

Injectable 1 ml/kg of 0.25% ropivacaine with 1mcg/kg dexmedetomidine DRUG

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.

Caudal Block

Injection of 0.5 ml/kg per side of injectable 0.2-0.3% ropivacaine with 0.5 mcg/kg dexmetomedine. DRUG

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.

Pudendal Block

Eligibility Criteria

• Age: 6 Months - 3 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Undergoing penile genitourinary surgery
• ASA class 1-3

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

UH Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Related Publications (8)

• 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.

  PMID: 30795645 BACKGROUND

• 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.

  PMID: 31415045 BACKGROUND

• 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.

  PMID: 30857607 BACKGROUND

• 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.

  PMID: 32819811 BACKGROUND

• 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.

  PMID: 33452203 BACKGROUND

• 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.

  PMID: 29205687 BACKGROUND

• 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.

  PMID: 27501015 BACKGROUND

• 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.

  PMID: 24257391 BACKGROUND

MeSH Terms

Conditions

Hypospadias; Phimosis

Interventions

Injections; Ropivacaine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jessica H Hannick, MD, MSc

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 1, 2023
• Study Start: March 6, 2023
• Primary Completion: February 1, 2025
• Study Completion: May 1, 2025
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)