Ultrasound-Guided Versus Conventional Method 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 supply 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. In particular ultrasonography under longitudinal image is helpful for visualization of the sacral hiatus, sacrococcygeal ligament, duramater, epidural space and the distribution of the local anesthetic agent Therefore, this significantly increases the block success and visualization of where local anesthetic is injected. 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. However age and weight encountered wtih these complications are registered.

Detailed Description
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The caudal block was performed in Group C by via conventional methods. The sacral cornus and the sacral hiatus were palpated. After sterilization of the region, a 22- gauge caudal needle was inserted into the skin with at a 60-80 degree angle and until the sacrococcygeal ligament was passed punctured, as determined with by a popping sensation. feeling (puncture of the sacrococcygeal ligament). Then, the angle of the needle was then reduced to 20-30 degrees and inserted further for an additional 2-3mm, entering into the sacral canal. After verifingverifying the absence of any blood or cerebrospinal fluid in the aspiration, a test dose of 0.1 ml/kg of local anesthetic (LA) with adrenalin at a ratio of 1: 200000 was injected under hemodynamic and ECG monitoring. Following a negative test dose, the rest of the LA was slowly injected slowly over 1 min. In the case of the needle touching the bony tissue, blood aspiration, or bulging into of the subcutaneous tissue, the angle of the needle was changed and the intervention was repeated. The caudal block was performed by via ultrasound guided ultrasound guidance in Group U. After sterilization of the region and using ultrasound guidanceUSG with a sterile plastic cover and gel, the sacral hiatus was visualized via an out-of-plane technique at the level of the sacral cornus at the out of plane via the lineerlinear transducer of an M-Turbo ultrasound machine (TM; Fujifilm SonoSite Inc., (Washington, WA, United StatesUSA) ultrasound machine at 13 MHz, and the, depth and gain was adjusted to for optimal visual quality. The ultrasound ultrasound transducer was first placed transversely at the midlain midline to obtain the transvers view of the two cornua, the sacrococcygeal ligament, the sacral bone, and the sacral hiatus. At this level, the ultrasound ultrasound transducer was rotated 90 degrees to obtain the longitudinal view of the sacrococcygeal ligamantligament and sacral hiatus, and was then placed between the two cornua. A 22- gauge caudal needle was advanced toward the upper third of the sacrococcygeal ligament. The needle advancement was terminated right after penetrating the sacrococcygeal ligament. At this level, after confirming the absence of any blood or cerebrospinal fluid in the aspiration and a negative test dose, the rest of the LA was injected over 1 min under while observing the ultrasound ultrasound longitudinal image

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

Conditions
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Ultrasound Therapy; Complications

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Adrenalin
* Device: Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA (American Society of Anesthesiologist) I children aged between 6 months and 8 years old who underwent elective hypospadias, circumcision and both surgery Exclusion Criteria: 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: 6 Months
Maximum Age: 8 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Group<br>Caudal block was performed by conventional method with %0,25 bupivacaine plus 1/200.000 adrenalin | Drug: Bupivacaine<br>* caudal block was performed by conventional and ultrasound method with %0,25 bupivacaine + 1/200000 adrenalin<br>* Other names: Bustesin,Vem Drug, Ankara, Turkey;Drug: Adrenalin<br>* caudal block was performed by conventional and ultrasound method with %0,25 bupivacaine + 1/200000 adrenalin<br>* Other names: Adrenalin 0.5 mg, Osel Drug, Istanbul, Turkey;|
| Active Comparator: Ultrasound Group<br>Caudal block was performed by ultrasound method with %0,25 bupivacaine plus 1/200.000 adrenalin | Drug: Bupivacaine<br>* caudal block was performed by conventional and ultrasound method with %0,25 bupivacaine + 1/200000 adrenalin<br>* Other names: Bustesin,Vem Drug, Ankara, Turkey;Drug: Adrenalin<br>* caudal block was performed by conventional and ultrasound method with %0,25 bupivacaine + 1/200000 adrenalin<br>* Other names: Adrenalin 0.5 mg, Osel Drug, Istanbul, Turkey;Device: Ultrasound<br>* caudal block was performed by ultrasound method<br>* Other names: Sonosite M Turbo, USA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate of block | absence of significant motor movements following surgical induction or aberrations in heart and or respiratory rates | Intraoperative period | 

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 | 
| complications | situations such as vascular puncture, bone contact, subcutaneous injection encountered, when the caudal block was performed, | Intraoperative first hour | 
| age and weight encountered complications | below which age and weight | Intraoperative first hour | 

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