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

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



Sponsors


Source

Baylor College of Medicine

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

Yes

Is Unapproved Device

No

Is Ppsd

No


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".

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.

Overall Status

Recruiting

Start Date

2017-06-30

Completion Date

2018-02-01

Primary Completion Date

2018-01-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Identify the rate at which blindly placed caudal blocks are not within the epidural space
15 minutes

Secondary Outcome

Measure

Time Frame

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

Enrollment

100

Condition


Intervention

Intervention Type

Diagnostic Test

Intervention Name


Description

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

Arm Group Label

Ultrasound


Eligibility

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

Gender

All

Minimum Age

N/A

Maximum Age

7 Years

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Adam C Adler, MD, FAAP
Principal Investigator
Texas Childrens Hospital

Overall Contact

Last Name

Adam C Adler, MD, FAAP

Phone

832-824-5800

Email



Location

Facility

Status

Contact

Texas childrens Hospital
Houston Texas 77030 United States
Recruiting
Last Name: Adam Adler, MD
Phone: 832-824-5800
Email: [email protected]

Location Countries

Country

United States


Verification Date

2017-09-01

Lastchanged Date

2017-09-13

Firstreceived Date

2017-09-12

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Baylor College of Medicine

Investigator Full Name

Adam Adler MD, MS, FAAP

Investigator Title

Assistant Professor


Has Expanded Access

No

Number Of Arms

1

Arm Group

Arm Group Label

Ultrasound

Arm Group Type

Experimental

Description

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.


Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Intervention Model

Single Group Assignment

Intervention Model Description

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

Primary Purpose

Treatment

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



ClinicalTrials.gov processed this data on September 14, 2017

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Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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