Does Use of Ultrasound Reduce the Rate of Sham Caudal Block in Children

Regional Anesthesia Morbidity Clinical Trial

Official title:

Does Use of Ultrasound Reduce the Rate of Sham Caudal Block in Children

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03283865
• Other study ID #: H-40844
• Status: Withdrawn
• Phase: N/A
• Start date: June 30, 2017
• Est. completion date: October 30, 2017

Study information

• Verified date: February 2020
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Caudal blocks are one of the most commonly performed regional anesthetics in children and are performed daily for a host of infra-umbilical surgical procedures. A caudal block is an epidural injection, most commonly of local anesthetic into the epidural space as accessed via the sacral hiatus. In children, the sacral hiatus is a normally occurring aperture in which the epidural space may be accessed with extremely minimal risk; as neural tissue ends more proximally. Due to this measure of safety, caudal blocks are preferred in children when compared with standard lumbar epidurals. Caudal blocks are performed blindly using palpation and tactile feedback to assess if the medication is being administered in the correct location. As a result of blind injection, administration of local anesthetic totally or partially outside of the correct site can often be unnoticed or identified after a significant volume has already been injected. With the potential for toxicity of local anesthetic, this may result in either the inability to give a complete dose or an unintentional and often unnoticed sham block "incorrect site of injection".

Description:

Caudal blocks are one of the most commonly performed regional anesthetics in children and are performed daily for a host of infra-umbilical surgical procedures. A caudal block is an epidural injection, most commonly of local anesthetic into the epidural space as accessed via the sacral hiatus. In children, the sacral hiatus is a normally occurring aperture in which the epidural space may be accessed with extremely minimal risk; as neural tissue ends more proximally. Due to this measure of safety, caudal blocks are preferred in children when compared with standard lumbar epidurals. Caudal blocks are performed blindly using palpation and tactile feedback to assess if the medication is being administered in the correct location. As a result of blind injection, administration of local anesthetic totally or partially outside of the correct site can often be unnoticed or identified after a significant volume has already been injected. With the potential for toxicity of local anesthetic, this may result in either the inability to give a complete dose or an unintentional and often unnoticed sham block "incorrect site of injection".

Use of ultrasound has been proposed for identification of caudal block placement and correct medication spread. However, a recent review of the Pediatric Regional Anesthesia Network database reveals that ultrasound is reportedly only used in less that 3% of blocks. The benefit of ultrasound is safe and real-time confirmation of injection. Ultrasound allows the provider to determine with minimal local anesthetic or even saline injection if the correct space is accessed. Without ultrasound, failed blocks are either identified after significant percentage of the total dose of local anesthetic is incorrectly administered or intra or post operatively when the patient demonstrates a significant opioid requirement. This is problematic given that one of the primary benefits of a caudal block in children is the ability to avoid opioids.

Review of local practice here at Texas Children's Hospital for quality improvement purposes revealed a failure rate of caudal blocks to be 18%. Failure was defined as a heart rate increase with incision of >20% despite a caudal block and >1MAC of gas for the patient age. These patients all required opioids both intra and post operatively in addition to surgical levels of inhaled anesthetic agent.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 30, 2017
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Years

Eligibility

Inclusion Criteria:

• Children ages 0-84 months

• Infra-umbilical procedure for which a caudal block is already planned

• American Society of Anesthesiology classifications of 1,2 or 3

Exclusion Criteria:

• Incarcerated hernias

• Emergency procedures

• Local Anesthetic allergy

• Sacral dimple

• Rash over sacrum

• Parents/legal guardians unable to consent for surgical procedure in English language Foster Care/Child protective services as guardians

• Parental Refusal for caudal block or study participation

• American Society of Anesthesiology classifications other than 1,2 or 3

Related Conditions & MeSH terms

• Regional Anesthesia Morbidity

Intervention

Diagnostic Test:
• Ultrasound guidance for caudal block
The attending anesthesiologist will perform or instruct the placement of a caudal block according to their standard of practice. At the time of administration of local anesthetic into the caudal space, the study collaborator (SC) will ultrasound the caudal space keeping the provider placing the block blinded to the imaging. The provider placing the block will inject 0.5mL of preservative free saline. The provider will then be asked to state if they are correctly in the caudal space or not. If the provider feels they are not in the caudal space, they will re-do the procedure. If the provider fails to identify incorrect location and this is noted by ultrasound, the SC will inform the provider to re-do the procedure

Locations

Country	Name	City	State
United States	Texas childrens Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify the rate at which blindly placed caudal blocks are not within the epidural space	Assess the percentage of providers not recognizing wrong site of injection without ultrasound	15 minutes
Secondary	Identify the rate at which ultrasound can guide a wrong block into the correct location	Assess the number of blocks that are require the use of ultrasound to redirect needle into caudal space	15 minutes
Secondary	Identify if lack of heart rate change on incision can predict successful placement when medication administration is successfully confirmed with ultrasound	With ultrasound identification of correct caudal injection, (successful block), does lack of heart rate change correlated with successful block	15 minutes
Secondary	Identify if after using ultrasound to visualize placement, if concentrations of inhaled agents may be reduced in children	With demonstration of successful caudal injection, can inhaled agent concentration be reduced as calculated by MAC hours	30 minutes to 3 hours