An interventional study of The use of classical Gauge 22 needle and The use of classical Gauge 27 needle in Anesthesia, Pain and Caudal Block, sponsored by University of Jordan. Completed at 1 site in Jordan. Open to participants aged 6 Months to 36 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-25.
Sponsored by University of Jordan · Not applicable, Interventional, and Prevention
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.
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.
University of Jordan is the lead sponsor of 126 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
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.
Opioids requirements intraoperatively
The investigators will document the required dose of opioids intraoperatively
Time frame: 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.
Time frame: 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.
Time frame: 210 minutes
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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University of Jordan