Pudendal Block Versus Caudal Block for Hypospadias

Phase 4

Completed

• Conditions: Pain
• Interventions: Procedure: pudendal nerve block; Procedure: caudal block

• Registration Number: NCT02390388
• Lead Sponsor: Istanbul University

Brief Summary

The aim of this prospective randomized study is to assess the analgesic efficacy and duration of Pudendal block compared with Caudal block for pediatric patients undergoing hypospadias surgery concerning intraoperative analgesic and also postoperative total analgesic consumption within 24 hours.

Detailed Description

In this prospective study, patients will be randomized into 2 groups, either receiving Caudal Block(CB) or nerve stimulator-guided Pudendal Nerve Block(PNB). Analgesic consumption will be assessed during the first 24 hours postoperatively. The "CHEOPS pain scale" will use to assess postoperative pain.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-01-26
• Study First Submitted QC: 2015-03-10
• Study First Posted: 2015-03-17
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-25
• Last Update Posted: 2015-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

• ASA physical status I-II
• aged 1 to 10 years scheduled undergoing hypospadias surgery

Exclusion Criteria

• history of allergic reactions to local anesthetics
• rash or infection at the injection site
• anatomical abnormality
• bleeding diatheses, coagulopathy, liver diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pudendal block group	pudendal nerve block	nerve stimulated pudendal nerve block performed under general anesthesia
Caudal block group	caudal block	caudal block performed under general anesthesia

Primary Outcome Measures

Name	Time	Method
postoperative pain intensity measure	24 hours	pain scores are recorded (postoperative within 24 hours) the investigators use CHEOPS pain scale for evaluation pain intensity. When pain score is 7 or higher than 7, pain treatment is evaluated as inadequate.

Secondary Outcome Measures

Name	Time	Method
time to to first use of analgesic	24 hours
the incidence of side effects	24 hours
postoperative total analgesic requirements	24 hours
parental satisfaction	24 hours	Parent satisfaction was scored as: 1. definitely unsatisfied; 2. satisfied; 3. definitely satisfied.
intraoperative analgesic requirement	intraoperative	intraoperative remifentanil infusion requirement ( If heart rate and/or blood pressure increase 20% than first measure, we will start remifentanil infusion)