Pudendal Block Versus Caudal Block for Hypospadias

A Comparison of Effectiveness of Pudendal Nerve Block vs Caudal Block for Hypospadias Surgery in Children

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02390388

Enrollment

Registered

2015-03-17

Start date

2014-11-30

Completion date

2015-05-31

Last updated

2015-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

pudendal block, Hypospadias, caudal block, child, analgesia

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.

Interventions

PROCEDUREpudendal nerve block

nerve stimulator-guided Pudendal block

PROCEDUREcaudal block

caudal block

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

MALE

Age

1 Years to 10 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
time to to first use of analgesic	24 hours	—
parental satisfaction	24 hours	Parent satisfaction was scored as: 1. definitely unsatisfied; 2. satisfied; 3. definitely satisfied.
the incidence of side effects	24 hours	—
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)
postoperative total analgesic requirements	24 hours	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026