Pudendal Block Versus Caudal Block for Hypospadias

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02390388
• Other study ID #: 242890
• Status: Completed
• Phase: Phase 4
• First received: January 26, 2015
• Last updated: August 25, 2015
• Start date: November 2014
• Est. completion date: May 2015

Study information

• Verified date: August 2015
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 1 Year to 10 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypospadias
• Pain

Intervention

Procedure:
• pudendal nerve block
nerve stimulator-guided Pudendal block
• caudal block
caudal block

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Istanbul University	Ayse Cigdem Tutuncu, Fatis Altindas, Guner Kaya, Senol Emre

References & Publications (1)

Naja ZM, Ziade FM, Kamel R, El-Kayali S, Daoud N, El-Rajab MA. The effectiveness of pudendal nerve block versus caudal block anesthesia for hypospadias in children. Anesth Analg. 2013 Dec;117(6):1401-7. doi: 10.1213/ANE.0b013e3182a8ee52. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain intensity measure	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.	24 hours	Yes
Secondary	time to to first use of analgesic		24 hours	Yes
Secondary	parental satisfaction	Parent satisfaction was scored as: definitely unsatisfied; satisfied; definitely satisfied.	24 hours	No
Secondary	the incidence of side effects		24 hours	Yes
Secondary	intraoperative analgesic requirement	intraoperative remifentanil infusion requirement ( If heart rate and/or blood pressure increase 20% than first measure, we will start remifentanil infusion)	intraoperative	Yes
Secondary	postoperative total analgesic requirements		24 hours	Yes