Pudendal Block Versus Penian Block For Circumcision In Children

NCT ID: NCT03046290

Last Updated: 2017-02-08

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-04-30

Brief Summary

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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).

Detailed Description

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Conditions

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Regional Anesthesia Postoperative Pain Circumcision

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

circumcision

Intervention Type PROCEDURE

Lidocaine

Intervention Type DRUG

Ropivacaine

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

circumcision

Intervention Type PROCEDURE

Lidocaine

Intervention Type DRUG

Ropivacaine

Intervention Type DRUG

Interventions

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circumcision

Intervention Type PROCEDURE

Lidocaine

Intervention Type DRUG

Ropivacaine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* circumcision in day surgery hospital

Exclusion Criteria

* allergy to amino-amide local anesthetics
* parental consent not received
* infection at injection site
Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Université Libre de Bruxelles

OTHER

Sponsor Role lead

Responsible Party

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JOHN NICOLARDOT

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hopital Erasme

Bruxelles Capitale, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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John Nicolardot, MD

Role: CONTACT

+3225555288

John Nicolardot

Role: CONTACT

Facility Contacts

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Hopital Erasme

Role: primary

+3225553111

References

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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.

Reference Type BACKGROUND
PMID: 21790518 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20849498 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22023417 (View on PubMed)

Other Identifiers

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U1111-1191-4760

Identifier Type: OTHER

Identifier Source: secondary_id

B406201630517

Identifier Type: -

Identifier Source: org_study_id

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