Skip to main content
OpenTrials
Completed

NCT Number: NCT04691531

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anesthesia Abdominal Surgeries Caudal Block Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pediatric Anesthesia Signs and Symptoms

Age range

6 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan University Hospital

Amman, 11942, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The use of classical Gauge 22 needle

Device

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

Device

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.

Primary outcomes

  1. Opioids requirements intraoperatively

    Time frame: 90 minutes

    The investigators will document the required dose of opioids intraoperatively

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 31, 2020
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.