Circumcision, Postoperative Pain, Regional Anesthesia
Conditions
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).
Interventions
PROCEDUREcircumcision
DRUGLidocaine
DRUGRopivacaine
Sponsors
Université Libre de Bruxelles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
1 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
* circumcision in day surgery hospital
Exclusion criteria
* allergy to amino-amide local anesthetics * parental consent not received * infection at injection site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pain score | pain score at 0 hours postoperatively | using the FLACC (Face Leg Activity Cry Consolability) Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree of satisfaction of the patient or his/her parents and the surgeon assessed by telephone interview | Day 5 after the procedure | telephone interview |
Countries
Belgium
Contacts
Primary ContactJohn Nicolardot, MD
Backup ContactJohn Nicolardot
Outcome results
None listed