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

NCT ID: NCT03145415

Last Updated: 2022-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-17

Study Completion Date

2019-12-20

Brief Summary

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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.

Detailed Description

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Hypospadias repair is one of the most common congenital malformations of the penis in the United States. It has an incidence of about 1 in 300 births. A combination of general anesthesia and a caudal block or general anesthesia combined with a pudendal nerve block are commonly used for hypospadias repair.

In our institution, hypospadias repair is typically done in infants and children ages 6 months to age two. A comparison of the efficacy of pudendal block versus the caudal block has not been undertaken in this younger population.

Conditions

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Hypospadias and Epispadias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

All Children will be randomly assigned to one of 2 groups of 30 patients each using a computer generated number table.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
No other parties will be masked.

Study Groups

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Bilateral Pudendal block

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

Group Type EXPERIMENTAL

Bilateral Pudendal block

Intervention Type 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

Caudal block

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

Group Type ACTIVE_COMPARATOR

Caudal block

Intervention Type PROCEDURE

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

Interventions

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Caudal block

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

Intervention Type PROCEDURE

Bilateral Pudendal block

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Boys undergoing hypospadias repair

Exclusion Criteria

\-
Minimum Eligible Age

6 Months

Maximum Eligible Age

2 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Nemours Children's Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nemours/ duPont Hospital for Children

Wilmington, Delaware, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36283712 (View on PubMed)

Other Identifiers

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lh0001

Identifier Type: -

Identifier Source: org_study_id

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