Pudendal Block Versus Penian Block For Circumcision In Children

Not Applicable

• Conditions: Regional Anesthesia; Postoperative Pain; Circumcision
• Interventions: Procedure: circumcision; Drug: Lidocaine; Drug: Ropivacaine

• Registration Number: NCT03046290
• Lead Sponsor: Université Libre de Bruxelles

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-10
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-07
• Last Update Submitted: 2017-02-07
• Study First Posted: 2017-02-08
• Last Update Posted: 2017-02-08
• Primary Completion: 2017-04
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• circumcision in day surgery hospital

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pudendal Block	circumcision	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.
Penian Block	circumcision	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.
Pudendal Block	Ropivacaine	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.
Pudendal Block	Lidocaine	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.
Penian Block	Lidocaine	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.
Penian Block	Ropivacaine	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.

Primary Outcome Measures

Name	Time	Method
postoperative pain score	pain score at 0 hours postoperatively	using the FLACC (Face Leg Activity Cry Consolability) Scale

Secondary Outcome Measures

Name	Time	Method
Degree of satisfaction of the patient or his/her parents and the surgeon assessed by telephone interview	Day 5 after the procedure	telephone interview

Trial Locations

Locations (1)

Hopital Erasme; 🇧🇪 Bruxelles Capitale, Belgium