Clinical trial NCT03283865: Does Use of Ultrasound Reduce the Rate of Sham Caudal Block in Children
Official title: Does Use of Ultrasound Reduce the Rate of Sham Caudal Block in Children
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Regional Anesthesia Morbidity
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2017-09-14
Enrollment: 0
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single blinded prospective trial in which all patients serve as their own clinical control group.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Identify the rate at which blindly placed caudal blocks are not within the epidural space
timeFrame: 15 minutes
Secondary outcomes:
measure: Identify the rate at which ultrasound can guide a wrong block into the correct location
timeFrame: 15 minutes
measure: Identify if lack of heart rate change on incision can predict successful placement when medication administration is successfully confirmed with ultrasound
timeFrame: 15 minutes
measure: Identify if after using ultrasound to visualize placement, if concentrations of inhaled agents may be reduced in children
timeFrame: 30 minutes to 3 hours
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas childrens Hospital
state: Texas
Study officials:
affiliation: Texas Childrens Hospital
name: Adam C Adler, MD, FAAP
role: PRINCIPAL_INVESTIGATOR
References: