Decreasing the Invasiveness of Ultrasound Guided Caudal Block: A Comparison Between 22-gauge and 27-guage Needles

Study Overview
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Brief Summary
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Ultrasound (US) has facilitated the use of caudal block in children and visualization of the needle during insertion. This prospective clinical trial study compares between two different sizes of the used needles, in terms of success rate, number of punctures, detection of the US signs (visualization of the needle, dural displacement, turbulence, and distention), and complications in pediatrics aging between 6-36 months requiring elective lower abdominal and perineal surgeries.

Detailed Description
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Ultrasound (US) has facilitated the use of caudal block in children, allowing an initial assessment of the anatomy of the sacrum, including the relationship of the sacral hiatus to the dural sac ending. Real-time US allows visualization of the needle during insertion to reach the dural sac, and to see the turbulence and distention of the layers during injection of the local anesthetic drug. This prospective clinical trial study compares between two different sizes of the used needles, in terms of success rate, number of punctures, detection of the US signs (visualization of the needle, dural displacement, turbulence, and distention), and complications in pediatrics aging between 6-36 months requiring elective lower abdominal and perineal surgeries.

Official Title
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Decreasing the Invasiveness of Ultrasound Guided Caudal Block: A Randomized Controlled Trial Comparing Between 22-gauge and 27-guage Needles

Conditions
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Anesthesia, Pain, Caudal Block, Pediatric Anesthesia, Abdominal Surgeries

Intervention / Treatment
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* Device: The use of classical Gauge 22 needle
* Device: The use of classical Gauge 27 needle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 6 months and 36 months Undergoing elective lower abdominal or perineal surgeries Exclusion Criteria: Refusal of the legal guardian of the patient. Patients aging less than 6 months, or older than 36 months. Emergency surgeries. Coagulopathy. infection at the site of procedure. Uncorrected hypovolemia. Increased intracranial pressure. Congenital anomalies at the site of procedure.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group C<br>After induction of general anesthesia, patients will undergo caudal block by classical Gauge 22 needle under ultrasound guidance using a linear probe 5.5-12 MHz, and Bupivacaine 1 ml/kg of 0.25% will be injected. | Device: The use of classical Gauge 22 needle<br>* After induction of general anesthesia, patients will undergo caudal block by using classical Gauge 22 needle under ultrasound guidance using a linear probe 5.5-12 MHz.<br>|
| Experimental: Group S<br>After induction of general anesthesia, patients will undergo caudal block by Gauge 27 needle under ultrasound guidance using a linear probe 5.5-12 MHz, and Bupivacaine 1 ml/kg of 0.25% will be injected. | Device: The use of classical Gauge 27 needle<br>* After induction of general anesthesia, patients will undergo caudal block by using Gauge 27 needle under ultrasound guidance using a linear probe 5.5-12 MHz.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioids requirements intraoperatively | The investigators will document the required dose of opioids intraoperatively | 90 minutes | 
| Pain score in the post-anesthesia care unit (PACU) | Pain score will be assessed regularly during the stay in the PACU using a pain scoring scale, where the score is interpreted from 0 to 10, in which 0 means no pain and 10 signifies very severe pain. | 120 minutes | 
| Peri-operative complications | Peri-operative complications related to the caudal block procedure will be documented from the start of the procedure till the discharge from the post-anesthesia care unit. | 210 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caudal block, Ultrasound, Pediatric anesthesia, Pain