Pudendal Block Versus Penian Block For Circumcision In Children

February 7, 2017 updated by: JOHN NICOLARDOT, Université Libre de Bruxelles

Pudendal Block Versus Penian Block For Circumcision In Children: A Double Blind Randomised Controlled Trial

The authors study the efficacy of the pudendal versus penile block for the relief of postoperative pain in children receiving ambulatory circumcision.

In this prospective, double-blind, randomized, parallel-arm trial, 60 children recruited during the anesthesia consultation will be allocated a general anesthesia with a pudendal block (PUD group) or a penile block (PEN group).

Each block will be made with equal parts lidocaine 1% and ropivacaine 0.75% (0.3 ml/kg).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles Capitale, Belgium, 1070
        • Recruiting
        • Hôpital Erasme
        • Contact:
        • Principal Investigator:
          • turgay tuna, MD, Ph D

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

1 year to 5 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • circumcision in day surgery hospital

Exclusion Criteria:

  • allergy to amino-amide local anesthetics
  • parental consent not received
  • infection at injection site

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: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Pudendal Block
The anesthesia is produced by blocking the pudendal nerves near the ischial spine of the pelvis.Local anesthetic (mixed of ropivacaine and lidocaine) is injected into the pudendal canal where the pudendal nerve is located.
Drug: Ropivacaine
Drug: Lidocaine
Procedure: circumcision
ACTIVE_COMPARATOR: Penian Block
The anesthesia is produced by blocking the dorsal penile nerves. Local anesthetic (mixed of ropivacaine and lidocaine)is injected under the pubis symphysis just below the Buck fascia where the nerve is located.
Drug: Ropivacaine
Drug: Lidocaine
Procedure: circumcision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain score
Time Frame: pain score at 0 hours postoperatively
using the FLACC (Face Leg Activity Cry Consolability) Scale
pain score at 0 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of satisfaction of the patient or his/her parents and the surgeon assessed by telephone interview
Time Frame: Day 5 after the procedure
telephone interview
Day 5 after the procedure

Collaborators and Investigators

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

Sponsor

Université Libre de Bruxelles

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

January 1, 2017

Primary Completion (ANTICIPATED)

April 1, 2017

Study Completion (ANTICIPATED)

April 1, 2017

Study Registration Dates

First Submitted

January 10, 2017

First Submitted That Met QC Criteria

February 7, 2017

First Posted (ESTIMATE)

February 8, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

February 8, 2017

Last Update Submitted That Met QC Criteria

February 7, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B406201630517
  • U1111-1191-4760 (OTHER: WHO UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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