Pudendal Block Versus Caudal Block for Hypospadias
A Comparison of Effectiveness of Pudendal Nerve Block vs Caudal Block for Hypospadias Surgery in Children
1 other identifier
interventional
80
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 pain
Started Nov 2014
Shorter than P25 for phase_4 pain
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 26, 2015
CompletedFirst Posted
Study publicly available on registry
March 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedAugust 26, 2015
August 1, 2015
6 months
January 26, 2015
August 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (5)
time to to first use of analgesic
24 hours
parental satisfaction
24 hours
the incidence of side effects
24 hours
intraoperative analgesic requirement
intraoperative
postoperative total analgesic requirements
24 hours
Study Arms (2)
pudendal block group
ACTIVE COMPARATORnerve stimulated pudendal nerve block performed under general anesthesia
Caudal block group
ACTIVE COMPARATORcaudal block performed under general anesthesia
Interventions
Eligibility Criteria
You may qualify if:
- ASA physical status I-II
- aged 1 to 10 years scheduled undergoing hypospadias surgery
You may not qualify if:
- history of allergic reactions to local anesthetics
- rash or infection at the injection site
- anatomical abnormality
- bleeding diatheses, coagulopathy, liver diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Istanbul Universitylead
- Ayse Cigdem Tutuncucollaborator
- Senol Emrecollaborator
- Fatis Altindascollaborator
- Kaya, Guner, M.D.collaborator
Related Publications (2)
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.
PMID: 24257391BACKGROUNDKendigelen P, Tutuncu AC, Emre S, Altindas F, Kaya G. Pudendal Versus Caudal Block in Children Undergoing Hypospadias Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):610-5. doi: 10.1097/AAP.0000000000000447.
PMID: 27501015DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Guner Kaya, Prof.
Istanbul University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.(Anesthesiology Specialist)
Study Record Dates
First Submitted
January 26, 2015
First Posted
March 17, 2015
Study Start
November 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
August 26, 2015
Record last verified: 2015-08