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

NCT03283865 | Withdrawn FDA Device

• 1 other identifier: H-40844
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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".

Conditions

Regional Anesthesia Morbidity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Identify the rate at which ultrasound can guide a wrong block into the correct location

  15 minutes

• Identify if lack of heart rate change on incision can predict successful placement when medication administration is successfully confirmed with ultrasound

  15 minutes

• Identify if after using ultrasound to visualize placement, if concentrations of inhaled agents may be reduced in children

  30 minutes to 3 hours

Study Arms (1)

Ultrasound

EXPERIMENTAL

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 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. All study participants will have ultrasound used for caudal block.

Diagnostic Test: Ultrasound guidance for caudal block

Interventions

Ultrasound guidance for caudal block DIAGNOSTIC_TEST

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

Ultrasound

Eligibility Criteria

• Age: Up to 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas childrens Hospital

Houston, Texas, 77030, United States

Location

Study Officials

• Adam C Adler, MD, FAAP

  Texas Childrens Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Single blinded prospective trial in which all patients serve as their own clinical control group. Provider doing the procedure will be blinded to intervention
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single blinded prospective trial in which all patients serve as their own clinical control group.

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 14, 2017
• Study Start: June 30, 2017
• Primary Completion: October 30, 2017
• Study Completion: October 30, 2017
• Last Updated: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)