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Clinical Trials/NCT04691531
NCT04691531
Completed
Not Applicable

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

University of Jordan1 site in 1 country100 target enrollmentJanuary 2, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia
Sponsor
University of Jordan
Enrollment
100
Locations
1
Primary Endpoint
Peri-operative complications
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2, 2021
End Date
April 20, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

omar ahmad ababneh

Principal investigator

University of Jordan

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Peri-operative complications

Time Frame: 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

Time Frame: 90 minutes

The investigators will document the required dose of opioids intraoperatively

Pain score in the post-anesthesia care unit (PACU)

Time Frame: 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.

Study Sites (1)

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