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

NCT04691531 | Completed

• 1 other identifier: 4599/2020/67
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Pain; Caudal Block; Pediatric Anesthesia; Abdominal Surgeries

Keywords

Caudal block; Ultrasound; Pediatric anesthesia; Pain

Outcome Measures

Primary Outcomes (3)

• Opioids requirements intraoperatively

  The investigators will document the required dose of opioids intraoperatively

  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.

  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.

  210 minutes

Study Arms (2)

group C

EXPERIMENTAL

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

Group S

EXPERIMENTAL

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

Interventions

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.

group C

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.

Group S

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age between 6 months and 36 months
• Undergoing elective lower abdominal or perineal surgeries

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

Jordan University Hospital

Amman, 11942, Jordan

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: December 31, 2020
• Study Start: January 2, 2021
• Primary Completion: April 20, 2022
• Study Completion: April 20, 2022
• Last Updated: January 25, 2023

Record last verified: 2023-01

Locations

JO (1)