Ultrasound-Guided Versus Conventional Injection for Caudal Block

Study Overview
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Brief Summary
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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.

Official Title
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Ultrasound-Guided Versus Conventional Injection for Caudal Block in Children

Conditions
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Ultrasound Therapy; Complications

Intervention / Treatment
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* Drug: Levobupivacaine
* Drug: Morphine Sulfate
* Device: Ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ultrasound guided caudal block<br>Caudal block was performed by ultrasound guided with %0,125 levobupivacaine + 10 mq/kg morphine | Drug: Levobupivacaine<br>* % 0,125 levobupivacaine<br>* Other names: ultrasound guided caudal block;Drug: Morphine Sulfate<br>* 10 mq/kg morphine sulfate<br>Device: Ultrasound<br>* Ultrasound guided caudal block<br>|
| Active Comparator: conventional caudal block<br>Caudal block was performed by conventional method with %0,125 levobupivacaine + 10 mq/kg morphine | Drug: Levobupivacaine<br>* % 0,125 levobupivacaine<br>* Other names: ultrasound guided caudal block;Drug: Morphine Sulfate<br>* 10 mq/kg morphine sulfate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate of block | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sacral hiatus, ultrasound guided caudal injection, sacral canal