Comparison of Pudendal Nerve Block and Caudal Block for Hypospadias in Young Children

NCT03145415 | Completed

• 1 other identifier: lh0001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized blinded prospective study is to compare the analgesic efficacy and duration of a Pudendal Nerve Block (PNB) to a Caudal Block (CB) for pediatric patients, ages 6 months to 2 years, undergoing hypospadias repair.

Conditions

Hypospadias and Epispadias

Keywords

pudendal nerve block; hypospadias; caudal block

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  The child's care giver will document the times that a rescue opioid was given to relieve pain.

  up to 24 hours

Secondary Outcomes (2)

• Intraoperative block assessment

  up to 3 hours

• Post operative pain

  up to 2 hours

Study Arms (2)

Bilateral Pudendal block

EXPERIMENTAL

0.25 cc per kg of 0.2% ropivacaine will be injected once for right pudendal N block and the same volume for the left pudendal N block before the start of the surgery

Procedure: Bilateral Pudendal block

Caudal block

ACTIVE COMPARATOR

1 cc per kg of 0.2% ropivacaine in the caudal space given before the start of surgery

Procedure: Caudal block

Interventions

Caudal block PROCEDURE

1 cc per kg of 0.2% ropivicaine in the caudal space given before the start of surgery.

Caudal block

Bilateral Pudendal block PROCEDURE

0.5 cc per kg of 0.2% ropivicaine. Half of the volume given as a right pudendal block and the remaining volume given on the left pudendal nerve block given prior to the start of surgery

Bilateral Pudendal block

Eligibility Criteria

• Age: 6 Months - 2 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Boys undergoing hypospadias repair

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Nemours/ duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Related Publications (1)

• Choudhry DK, Heredia L, Brenn BR, Brown M, Carvalho NF, Whaley MC, Shaik SS, Hagerty JA, Bani Hani A. Nerve stimulation guided bilateral pudendal nerve block versus landmark-based caudal block for hypospadias repair in young children: a prospective, randomized, pragmatic trial. Reg Anesth Pain Med. 2022 Dec;47(12):744-748. doi: 10.1136/rapm-2022-103680. Epub 2022 Sep 8.

  PMID: 36283712 DERIVED

MeSH Terms

Conditions

Hypospadias; Epispadias

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; Urethral Diseases; Urologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: No other parties will be masked.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All Children will be randomly assigned to one of 2 groups of 30 patients each using a computer generated number table.

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 9, 2017
• Study Start: February 17, 2017
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: May 19, 2022

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)