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

Not Applicable

Completed

• Conditions: Abdominal Surgeries; Caudal Block; Pain; Pediatric Anesthesia; Anesthesia
• Interventions: Device: The use of classical Gauge 27 needle; Device: The use of classical Gauge 22 needle

• Registration Number: NCT04691531
• Lead Sponsor: University of Jordan

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-12-28
• Study First Submitted QC: 2020-12-30
• Study First Posted: 2020-12-31
• Study Start: 2021-01-02
• Primary Completion: 2022-04-20
• Study Completion: 2022-04-20
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-23
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group S	The use of classical Gauge 27 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.
group C	The use of classical Gauge 22 needle	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.

Primary Outcome Measures

Name	Time	Method
Peri-operative complications	210 minutes	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.
Opioids requirements intraoperatively	90 minutes	The investigators will document the required dose of opioids intraoperatively
Pain score in the post-anesthesia care unit (PACU)	120 minutes	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.

Trial Locations

Locations (1)

Jordan University Hospital; 🇯🇴 Amman, Jordan