NCT03046290

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 8, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

3 months

First QC Date

January 10, 2017

Last Update Submit

February 7, 2017

Conditions

Regional AnesthesiaPostoperative PainCircumcision

Outcome Measures

Primary Outcomes (1)

  • postoperative pain score

    using the FLACC (Face Leg Activity Cry Consolability) Scale

    pain score at 0 hours postoperatively

Secondary Outcomes (1)

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

    Day 5 after the procedure

Study Arms (2)

Pudendal Block

ACTIVE COMPARATOR

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.

Procedure: circumcisionDrug: LidocaineDrug: Ropivacaine

Penian Block

ACTIVE COMPARATOR

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.

Procedure: circumcisionDrug: LidocaineDrug: Ropivacaine

Interventions

circumcisionPROCEDURE
Penian BlockPudendal Block
LidocaineDRUG
Penian BlockPudendal Block
RopivacaineDRUG
Penian BlockPudendal Block

Eligibility Criteria

Age1 Year - 5 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • circumcision in day surgery hospital

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Erasme

Bruxelles Capitale, 1070, Belgium

RECRUITING

Related Publications (3)

  • 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.

    PMID: 21790518BACKGROUND

  • 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.

    PMID: 20849498BACKGROUND

  • 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.

    PMID: 22023417BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Circumcision, MaleLidocaineRopivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Body Modification, Non-TherapeuticCosmetic TechniquesTherapeuticsSurgical Procedures, OperativeUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

John Nicolardot, MD

CONTACT

+3225555288nicolardotjohn@gmail.com

John Nicolardot

CONTACT

nicolardotjohn@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 10, 2017

First Posted

February 8, 2017

Study Start

January 1, 2017

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

February 8, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)