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Pudendal Block Versus Penian Block For Circumcision In Children

Primary Purpose

Regional Anesthesia, Postoperative Pain, Circumcision

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
circumcision
Lidocaine
Ropivacaine
Sponsored by
Université Libre de Bruxelles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Regional Anesthesia

Eligibility Criteria

1 Year - 5 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • circumcision in day surgery hospital

Exclusion Criteria:

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

Sites / Locations

  • Hopital ErasmeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pudendal Block

Penian Block

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

postoperative pain score
using the FLACC (Face Leg Activity Cry Consolability) Scale

Secondary Outcome Measures

Degree of satisfaction of the patient or his/her parents and the surgeon assessed by telephone interview
telephone interview

Full Information

First Posted
January 10, 2017
Last Updated
February 7, 2017
Sponsor
Université Libre de Bruxelles
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1. Study Identification

Unique Protocol Identification Number
NCT03046290
Brief Title
Pudendal Block Versus Penian Block For Circumcision In Children
Official Title
Pudendal Block Versus Penian Block For Circumcision In Children: A Double Blind Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université Libre de Bruxelles

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Regional Anesthesia, Postoperative Pain, Circumcision

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pudendal Block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Penian Block
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
circumcision
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Primary Outcome Measure Information:
Title
postoperative pain score
Description
using the FLACC (Face Leg Activity Cry Consolability) Scale
Time Frame
pain score at 0 hours postoperatively
Secondary Outcome Measure Information:
Title
Degree of satisfaction of the patient or his/her parents and the surgeon assessed by telephone interview
Description
telephone interview
Time Frame
Day 5 after the procedure

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: circumcision in day surgery hospital Exclusion Criteria: allergy to amino-amide local anesthetics parental consent not received infection at injection site
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John Nicolardot, MD
Phone
+3225555288
Email
nicolardotjohn@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
John Nicolardot
Email
nicolardotjohn@gmail.com
Facility Information:
Facility Name
Hopital Erasme
City
Bruxelles Capitale
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hopital Erasme
Phone
+3225553111
Email
nicolardotjohn@gmail.com
First Name & Middle Initial & Last Name & Degree
turgay tuna, MD, Ph D

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21790518
Citation
Naja Z, Al-Tannir MA, Faysal W, Daoud N, Ziade F, El-Rajab M. A comparison of pudendal block vs dorsal penile nerve block for circumcision in children: a randomised controlled trial. Anaesthesia. 2011 Sep;66(9):802-7. doi: 10.1111/j.1365-2044.2011.06753.x. Epub 2011 Jul 25.
Results Reference
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PubMed Identifier
20849498
Citation
Faraoni D, Gilbeau A, Lingier P, Barvais L, Engelman E, Hennart D. Does ultrasound guidance improve the efficacy of dorsal penile nerve block in children? Paediatr Anaesth. 2010 Oct;20(10):931-6. doi: 10.1111/j.1460-9592.2010.03405.x.
Results Reference
background
PubMed Identifier
22023417
Citation
O'Sullivan MJ, Mislovic B, Alexander E. Dorsal penile nerve block for male pediatric circumcision--randomized comparison of ultrasound-guided vs anatomical landmark technique. Paediatr Anaesth. 2011 Dec;21(12):1214-8. doi: 10.1111/j.1460-9592.2011.03722.x.
Results Reference
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Pudendal Block Versus Penian Block For Circumcision In Children

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