Pudendal Block Versus Caudal Block for Hypospadias

August 25, 2015 updated by: pinar kendigelen, Istanbul University

A Comparison of Effectiveness of Pudendal Nerve Block vs Caudal Block for Hypospadias Surgery in Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: pudendal block group
nerve stimulated pudendal nerve block performed under general anesthesia
Procedure: pudendal nerve block
nerve stimulator-guided Pudendal block
Active Comparator: Caudal block group
caudal block performed under general anesthesia
Procedure: caudal block
caudal block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain intensity measure
Time Frame: 24 hours
pain scores are recorded (postoperative within 24 hours) the investigators use CHEOPS pain scale for evaluation pain intensity. When pain score is 7 or higher than 7, pain treatment is evaluated as inadequate.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to to first use of analgesic
Time Frame: 24 hours
24 hours
parental satisfaction
Time Frame: 24 hours

Parent satisfaction was scored as:

  1. definitely unsatisfied;
  2. satisfied;
  3. definitely satisfied.
24 hours
the incidence of side effects
Time Frame: 24 hours
24 hours
intraoperative analgesic requirement
Time Frame: intraoperative
intraoperative remifentanil infusion requirement ( If heart rate and/or blood pressure increase 20% than first measure, we will start remifentanil infusion)
intraoperative
postoperative total analgesic requirements
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Collaborators

Ayse Cigdem Tutuncu
Senol Emre
Fatis Altindas
Kaya, Guner, M.D.

Investigators

  • Study Director: Guner Kaya, Prof., Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

January 26, 2015

First Submitted That Met QC Criteria

March 10, 2015

First Posted (Estimate)

March 17, 2015

Study Record Updates

Last Update Posted (Estimate)

August 26, 2015

Last Update Submitted That Met QC Criteria

August 25, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 242890

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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