Pudendal Block Versus Caudal Block for Hypospadias

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

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-05-31

Brief Summary

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The aim of this prospective randomized study is to assess the analgesic efficacy and duration of Pudendal block compared with Caudal block for pediatric patients undergoing hypospadias surgery concerning intraoperative analgesic and also postoperative total analgesic consumption within 24 hours.

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Detailed Description

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In this prospective study, patients will be randomized into 2 groups, either receiving Caudal Block(CB) or nerve stimulator-guided Pudendal Nerve Block(PNB). Analgesic consumption will be assessed during the first 24 hours postoperatively. The "CHEOPS pain scale" will use to assess postoperative pain.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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pudendal block group

nerve stimulated pudendal nerve block performed under general anesthesia

Group Type ACTIVE_COMPARATOR

pudendal nerve block

Intervention Type PROCEDURE

nerve stimulator-guided Pudendal block

Caudal block group

caudal block performed under general anesthesia

Group Type ACTIVE_COMPARATOR

caudal block

Intervention Type PROCEDURE

caudal block

Interventions

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pudendal nerve block

nerve stimulator-guided Pudendal block

Intervention Type PROCEDURE

caudal block

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ASA physical status I-II
* aged 1 to 10 years scheduled undergoing hypospadias surgery

Exclusion Criteria

* history of allergic reactions to local anesthetics
* rash or infection at the injection site
* anatomical abnormality
* bleeding diatheses, coagulopathy, liver diseases

Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No