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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04691531
• Other study ID #: 4599/2020/67
• Status: Completed
• Phase: N/A
• Start date: January 2, 2021
• Est. completion date: April 20, 2022

Study information

• Verified date: January 2023
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 20, 2022
• Est. primary completion date: April 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 36 Months

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Surgeries
• Anesthesia
• Caudal Block
• Pain
• Pediatric Anesthesia

Intervention

Device:
• The use of classical Gauge 22 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.
• The use of classical Gauge 27 needle
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.

Locations

Country	Name	City	State
Jordan	Jordan University Hospital	Amman

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioids requirements intraoperatively	The investigators will document the required dose of opioids intraoperatively	90 minutes
Primary	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
Primary	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