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Trial record 24 of 834 for:    Texas Children's Hospital | ( Map: United States )

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

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ClinicalTrials.gov Identifier: NCT03283865
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
Adam Adler MD, MS, FAAP, Baylor College of Medicine

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".

Condition or disease Intervention/treatment Phase
Regional Anesthesia Morbidity Diagnostic Test: Ultrasound guidance for caudal block Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single blinded prospective trial in which all patients serve as their own clinical control group.
Masking: None (Open Label)
Masking Description:

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

Provider doing the procedure will be blinded to intervention

Primary Purpose: Treatment
Official Title: Does Use of Ultrasound Reduce the Rate of Sham Caudal Block in Children
Actual Study Start Date : June 30, 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Ultrasound

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
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




Primary Outcome Measures :
  1. Identify the rate at which blindly placed caudal blocks are not within the epidural space [ Time Frame: 15 minutes ]
    Assess the percentage of providers not recognizing wrong site of injection without ultrasound


Secondary Outcome Measures :
  1. Identify the rate at which ultrasound can guide a wrong block into the correct location [ Time Frame: 15 minutes ]
    Assess the number of blocks that are require the use of ultrasound to redirect needle into caudal space

  2. Identify if lack of heart rate change on incision can predict successful placement when medication administration is successfully confirmed with ultrasound [ Time Frame: 15 minutes ]
    With ultrasound identification of correct caudal injection, (successful block), does lack of heart rate change correlated with successful block

  3. Identify if after using ultrasound to visualize placement, if concentrations of inhaled agents may be reduced in children [ Time Frame: 30 minutes to 3 hours ]
    With demonstration of successful caudal injection, can inhaled agent concentration be reduced as calculated by MAC hours



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03283865


Contacts
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Contact: Adam C Adler, MD, FAAP 832-824-5800 axadler@texaschildrens.org

Locations
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United States, Texas
Texas childrens Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Adam Adler, MD    832-824-5800    axadler@texaschildrens.org   
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Adam C Adler, MD, FAAP Texas Childrens Hospital

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Responsible Party: Adam Adler MD, MS, FAAP, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03283865     History of Changes
Other Study ID Numbers: H-40844
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No