Pudendal Block Versus Penian Block For Circumcision In Children

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03046290
• Other study ID #: B406201630517
• Secondary ID: U1111-1191-4760
• Status: Recruiting
• Phase: N/A
• First received: January 10, 2017
• Last updated: February 7, 2017
• Start date: January 2017
• Est. completion date: April 2017

Study information

• Verified date: February 2017
• Source: Université Libre de Bruxelles
• Contact: John Nicolardot, MD
• Phone: +3225555288
• Email: nicolardotjohn[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 1 Year to 5 Years

Eligibility

Inclusion Criteria:

• circumcision in day surgery hospital

Exclusion Criteria:

• allergy to amino-amide local anesthetics

• parental consent not received

• infection at injection site

Related Conditions & MeSH terms

• Circumcision
• Pain, Postoperative
• Postoperative Pain
• Regional Anesthesia

Intervention

Procedure:
• circumcision

Drug:
• Lidocaine

• Ropivacaine

Locations

Country	Name	City	State
Belgium	Hopital Erasme	Bruxelles Capitale

Sponsors (1)

Lead Sponsor	Collaborator
Université Libre de Bruxelles

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain score	using the FLACC (Face Leg Activity Cry Consolability) Scale	pain score at 0 hours postoperatively
Secondary	Degree of satisfaction of the patient or his/her parents and the surgeon assessed by telephone interview	telephone interview	Day 5 after the procedure