- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03496740
Ultrasound Guided Penile Block vs Pudendal Block for Hypospadias
November 23, 2018 updated by: Can AKSU, Kocaeli University
Ultrasound Guided Dorsal Penile Block vs Neurostimulator Guided Pudendal Block in Children Undergoing Hypospadias Surgery: A Prospective, Randomized, Double-Blind Trial
Pain after hypospadias surgery is a challenging issue to solve for anesthesists.
Many different analgesia techniques were defined in literature for this purpose.
The investigators have implemented application of ultrasound guided dorsal penile nerve block into practice for these type of surgeries.
Main purpose of this study is to compare the efficacy of nerve stimulator guided pudendal nerve block with ultrasound guided dorsal penile nerve block for postoperative analgesia after hypospadias surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kocaeli
-
İzmit, Kocaeli, Turkey, 41340
- Kocaeli University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 months to 8 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 1 to 10 years of age
- ASA I-II
- Undergoing elective hypospadias surgery
Exclusion Criteria:
- infection of the skin at the site of needle puncture area
- patients with known allergies to any of the study drugs
- coagulopathy
- ASA III-IV
- Patients with neurological disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Penile Block
Ultrasound guided dorsal penile nerve block will be administered after general anesthesia. 0,25% Bupivacaine 0,5ml/kg (max. 20ml) will be used for the blocks |
Ultrasound guided dorsal penile nerve block will be done to this group of patients preoperatively, under general anesthesia.
0,25% Bupivacaine 0,5ml/kg (max.
20ml)
Block drug
|
Active Comparator: Pudendal Block
Nerve stimulator-guided pudendal block.
0,25% Bupivacaine 0,5ml/kg (max.
20ml) will be used for the blocks
|
Block drug
Nerve stimulation guided bilateral pudendal block will be done to this group of patients preoperatively, under general anesthesia.
0,25% Bupivacaine 0,5ml/kg (max.
20ml)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to first analgesic
Time Frame: postoperative 7 day
|
First need for rescue analgesic after the surgery will be recorded
|
postoperative 7 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Scores
Time Frame: postoperative 48 hour
|
FLACC scale will be used.
The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain.
The scale is scored in a range of 0-10 with 0 representing no pain.
The scale has five criteria, which are each assigned a score of 0, 1 or 2.
|
postoperative 48 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2018
Primary Completion (Actual)
November 23, 2018
Study Completion (Actual)
November 23, 2018
Study Registration Dates
First Submitted
April 5, 2018
First Submitted That Met QC Criteria
April 11, 2018
First Posted (Actual)
April 12, 2018
Study Record Updates
Last Update Posted (Actual)
November 27, 2018
Last Update Submitted That Met QC Criteria
November 23, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Urogenital Abnormalities
- Congenital Abnormalities
- Penile Diseases
- Pain, Postoperative
- Hypospadias
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
- Bupivacaine
Other Study ID Numbers
- 2017-379
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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