- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03337191
Ultrasound-Guided Versus Conventional Injection for Caudal Block
Ultrasound-Guided Versus Conventional Injection for Caudal Block in Children
Caudal epidural block has been widely used, especially in pediatric surgery, to provide intraoperative and postoperative analgesia by affecting the region between T10 and S5 dermatomes in surgeries below the umbilical level.
In conventional single-shot caudal block, the needle is inserted through the skin with a 60-80 degrees angle, until the sacrococcygeal ligament is passed through. Then the angle of the needle is decreased to 20-30 degrees and inserted further for an additional 2-3 mm, entering into the sacral canal.There is a risk of dural or vascular puncture when the needle is passing through sacral canal. Other complications are the soft tissue bulging, intraosseous injections and systemic toxicity.
Many anatomical variations have been reported for sacral hiatus and sacral cornua. Therefore, the success rate of the classic caudal epidural anesthesia method in pediatric patients has been reported to be about 75%.
With the usage of ultrasonography in regional anesthesia, many advantages have been reported. Ultrasonography is helpful for visualization of the sacral hiatus, sacrococcygeal ligament, duramater, epidural space and the distribution of the local anesthetic agent within the epidural space. Therefore, this significantly increases the block success.
The primary aim of this study was compare the success rate of ultrasound guided sacral hiatus injection and conventional sacral canal injection. Secondary objectives are; block performing time, number of needle puncture, success at first puncture and complication rate.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Erzurum, Turkey
- Ataturk University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- American Society of Anesthesiologist's physiologic state I-II patients undergoing phimosis and circumcision surgery
Exclusion Criteria:
- children with severe systemic disease
- previous neurological or spinal disorder,
- coagulation anomaly
- allergy against local anesthetics
- local infection at block site or
- with a history of premature birth
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ultrasound guided caudal block
Caudal block was performed by ultrasound guided with %0,125 levobupivacaine + 10 mq/kg morphine
|
% 0,125 levobupivacaine
Other Names:
10 mq/kg morphine sulfate
Ultrasound guided caudal block
|
Active Comparator: conventional caudal block
Caudal block was performed by conventional method with %0,125 levobupivacaine + 10 mq/kg morphine
|
% 0,125 levobupivacaine
Other Names:
10 mq/kg morphine sulfate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
success rate of block
Time Frame: Intraoperative first hour
|
A successful block was defined as absence of significant motor movements following surgical induction or heart and respiratory rates increasing not more than 20% of the basal levels.
|
Intraoperative first hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
block performing time
Time Frame: Intraoperative first hour
|
The block time was defined as the period between the insertion of the needle and termination of local anesthetic administration
|
Intraoperative first hour
|
first puncture success rate
Time Frame: Intraoperative first hour
|
The first puncture success rate was defined as reaching the sacral canal or sacral hiatus with a single-needle orientation on the first puncture without any withdrawal from the skin.
|
Intraoperative first hour
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Dostbil A, Gursac Celik M, Aksoy M, Ahiskalioglu A, Celik EC, Alici HA, Ozbey I. The effects of different doses of caudal morphine with levobupivacaine on postoperative vomiting and quality of analgesia after circumcision. Anaesth Intensive Care. 2014 Mar;42(2):234-8. doi: 10.1177/0310057X1404200211.
- Wang LZ, Hu XX, Zhang YF, Chang XY. A randomized comparison of caudal block by sacral hiatus injection under ultrasound guidance with traditional sacral canal injection in children. Paediatr Anaesth. 2013 May;23(5):395-400. doi: 10.1111/pan.12104. Epub 2012 Dec 29.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Caudal Ataturk Uni
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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