Does Use of Ultrasound Reduce the Rate of Sham Caudal Block in Children
Phase: NA
Conditions: Regional Anesthesia Morbidity
Sponsor: Baylor College of Medicine

 
 
  
Institutional Review Board for Baylor College of Medicine and Affiliated 
Hospitals 
  
Protocol Number:    H-40844
Status:                        Closed 
Initial Submit Date:  5/4/2017 
  
Section Aa:  Title & PI 
A1.  Main Title 
    DOES USE OF ULTRASOUND REDUCE THE RATE OF SHAM CAUDAL BLOCK IN CHILDREN WHEN 
COMPARED TO BLIND TECHNIQUE 
A2.  Principal Investigator 
  
    Name:   
ADAM ADLER 
Phone:   
832-824-5800 
    Id:   
195273 
Fax:   
    Department:   TCH ANESTHESIOLOGY 
Email:    
acadler@bcm.tmc.edu 
    Center:   
Mail Stn:   BCM320 
A3.  Administrative Contact 
  
    Name: 
KIMBERLY MAYFIELD 
Phone:   
832-824-5800 
    Id:   
160158 
Fax:   
    
Email:    
kmayfiel@bcm.tmc.edu 
    
Mail Stn:   BCM320 
  
Section Ab:  General Information     
A4.  Co-Investigators 
  
    Name:   
NIHAR PATEL 
Phone:   
832-824-5800 
Id:   
039846 
Fax:   
Department:   TCH ANESTHESIOLOGY 
Email:    
nvp1@bcm.tmc.edu 
Center:   
Mail Stn:   BCM320 
  
    Name:   
DEAN ANDROPOULOS 
Phone:   
832-826-5822 
Id:   
041898 
Fax:   
832-825-1903 
Department:   TCH ANESTHESIOLOGY 
Email:    
dra@bcm.tmc.edu 
Center:   
Mail Stn:   BCM320 
  
    Name:   
PAUL HOPKINS 
Phone:   
832-824-5800 
Id:   
150302 
Fax:   
832-825-5801 
Department:   TCH ANESTHESIOLOGY 
Email:    
hopkins@bcm.tmc.edu 
Center:   
Mail Stn:   BCM320 

  
    Name:   
CAITLIN SUTTON 
Phone:   
832-824-5809 
Id:   
160350 
Fax:   
Department:   ANESTHESIOLOGY: BCM 
Email:    
cdsutton@bcm.tmc.edu 
Center:   
Mail Stn:   BCM320 
  
    Name:   
ARVIND CHANDRAKANTAN 
Phone:   
832-824-5800 
Id:   
195204 
Fax:   
Department:   TCH ANESTHESIOLOGY 
Email:    
chandrak@bcm.tmc.edu 
Center:   
Mail Stn:   BCM320 
  
    Name:   
KARLA WYATT 
Phone:   
832-824-5800 
Id:   
195530 
Fax:   
Department:   TCH ANESTHESIOLOGY 
Email:    
kewyatt@bcm.tmc.edu 
Center:   
Mail Stn:   BCM320 
A5.  Funding Source: 
    Baylor College of Medicine (Internal Funding Only) 
A6a.  Institution(s) where work will be performed: 
    TCH: Texas Children's Hospital 
A6b.  Research conducted outside of the United States: 
    
Country:   
Facility/Institution:   
Contact/Investigator:   
Phone Number:   
If documentation of assurances has not been sent to the Office of Research, please explain: 
A7.  Research Category: 
    
A8. Therapeutic Intent 
Does this trial have therapeutic intent? 
    Not set yet
  
A9. ClinicalTrails.gov Registration 
  
Section B:  Exempt Request 
B.  Exempt From IRB Review 
    Not Applicable
  
Section C:  Background Information 

    
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. 
  
Section D:  Purpose and Objectives 
    
1) Identify the rate at which blindly placed caudal blocks are not within the epidural space 2) Identify the rate at 
which ultrasound can guide a wrong block into the correct location 3) Identify if lack of heart rate change on 
incision can predict successful placement when medication administration is successfully confirmed with 
ultrasound 4) Identify if after using ultrasound to visualize placement, if concentrations of inhaled agents may 
be reduced in children 
  
Section E:  Protocol Risks/Subjects 
E1.  Risk Category 
    Category 1: Research not involving greater than minimum risk. 
E2.  Subjects 
Gender: 
    Both
Age: 
    Child (3-12 yrs), Infant/Toddler (0-36 mos) 
Ethnicity: 
    All Ethnicities
Primary Language: 
    English, Spanish
Groups to be recruited will include: 

    Patients
Which if any of the following vulnerable populations will be recruited as subjects? 
    Children
Vulnerable populations require special protections.  How will you obtain informed consent, protect subject 
confidentiality, and prevent undue coercion? 
    
Consent will only be obtained from parents/legal guardians. Confidentiality will be maintained by the PI as no 
patient or provider specific identifiers will be recored aside from consent parental signature. To avoid undue 
coercion, consenting parents/guardians will be informed that there willingness to participate will not affect their 
child's treatment course or ability to get a caudal block or have any impact on their care course. 
E3.  Pregnant woman/fetus 
Will pregnant women and/or fetuses (as described in 45 CFR 46 Subpart B) be enrolled in the research? 
    No
E4.  Neonates 
Will neonates of uncertain viability or nonviable neonates (as described in 45 CFR 46 Subpart B) be enrolled in the 
research? 
    No
E5.  Children 
Will children be enrolled in the research? 
    Yes
  
Section F:  Design/Procedure 
F1.  Design 
Select one category that most adequately describes your research: 
    c) Pilot
Discuss the research design including but not limited to such issues as: probability of group assignment, potential 
for subject to be randomized to placebo group, use of control subjects, etc. 
    Single blinded prospective trial in which all patients serve as their own clinical control group. 
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: 
    
Associated procedures for which caudal does not provide complete analgesia Incarcerated hernias Emergency 
procedures Local Anesthetic allergy Sacral dimple Rash over sacrum precluding block 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 
F2.  Procedure 
    
Patients meeting inclusion criteria and following informed consent will be brought back to the operating room. 
General anesthesia will be induced in the standard manner either by inhalation induction or intravenous 
induction at the discretion of the anesthesia attending of record. The airway will be secured using an 

age/weight appropriately sized device, at the discretion of the anesthesia attending of record. The caudal block 
will ensue in the same manner regardless of the study at the discretion of the anesthesia attending of record. 
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. After a successful injection (as confirmed by 
ultrasound) is performed, the patient will be prepped for the procedure in standard manner. The inhaled 
anesthetic will be titrated until the minimal alveolar concentration is between 0.8-1 MAC for age prior to 
incision. The anesthesia provider will note the heart rate immediately before and after the first surgical 
stimulation. Data will be recorded de-identified on the sheet (see attached). The study PI will compare MAC 
hours (exposure to inhaled anesthetic agent) in patients having undergone caudal block with ultrasound 
confirmation to those in the retrospective group gathered for quality improvement to ascertain if reduction of 
exposure to inhaled agent was possible. 
  
Section G:  Sample Size/Data Analysis 
G1.  Sample Size 
How many subjects (or specimens, or charts) will be used in this study? 
    Local: 150              Worldwide: 150 
Please indicate why you chose the sample size proposed: 
    
A previous study using ultrasound in children for caudal block demonstrated an incidence of 7.1% 
subcutaneous bulging (failed block) when ultrasound was not used. Using our primary outcome of 
determination of block failure rate when performing blind (without ultrasound) and assuming a difference of 
20% increase in success rate would alter practice and thus be clinically significant using a one sample mean, 
alpha of 0.05 and a power of 80% would require an enrollment of 99 patients, each serving as their own 
control. Assuming a study dropout rate of 10% (unknown sacral dimple, etc.) and requirement for additional 
patients to perform secondary statistical analyses, 150 patients will be enrolled. Analysis performed with JMP 
statistical software. 
G2.  Data Analysis 
Provide a description of your plan for data analysis. State the types of comparisons you plan (e.g. comparison of 
means, comparison of proportions, regressions, analysis of variance). Which is the PRIMARY 
comparison/analysis? How will the analyses proposed relate to the primary purposes of your study? 
    
Data will be presented as means +/-SD, median (range) and number % when appropriate. Continuous 
variables will be compared with independent sample t-test or Mann-Whitney U testing for normally distributed 
data. Odds ratios will be noted for the primary outcome with confidence intervals displayed to achieve CI of 
95%. Statistics will be aided by JMP software with P values of <0.05 considered significant. 
  
Section H:  Potential Risks/Discomforts 
Describe and assess any potential risks/discomforts; (physical, psychological, social, legal, or other) and assess 
the likelihood and seriousness of such risks: 
    There are no potential risk of discomfort to the patients As with all studies, there is a small risk of loss of 
confidentiality or data breech. 
  
Section I:  Potential Benefits 

Describe potential benefit(s) to be gained by the individual subject as a result of participating in the planned work. 
    
Patient: For the individual patient enrolled, there will be no deviation from the standard of practice of either the 
anesthetic or regional block. As nearly all providers perform this technique blindly, the patient will have the 
benefit of immediate recognition of incorrect block eliminating the possibility for inadvertent sham block. In 
addition, reduced block failure will result in less exposure to opioids and inhaled anesthetic agents. 
Describe potential benefit(s) to society of the planned work. 
    
The benefit from this study, should it show that ultrasound is superior for recognizing incorrect placement when 
compared with blind technique is that fewer inadvertent sham blocks may be performed. Additionally, if 
reduction of block failure by use of ultrasound can be established, reduced exposure to inhaled anesthetics 
which have potential adverse effects on neurodevelopment may be possible 
Do anticipated benefits outweigh potential risks? Discuss the risk-to-benefit ratio. 
    
The study benefits the participant that would undergo a caudal block using a blind technique in that immediate 
recognition of sham block would be possible allowing for correction of placement. The study would reduce the 
risk for patients undergoing caudal blocks with incorrect placement that provide a risk of the block with no 
benefit. This allows the patient to either benefit from the block or avoid wrongly placed medication should the 
block be aborted. As with all studies, there is a small risk of loss of confidentiality or data breech. 
  
Section J:  Consent Procedures 
J1.  Waiver of Consent 
Will any portion of this research require a waiver of consent and authorization? 
    NA
  
J1a.  Waiver of requirement for written documentation of Consent 
Will this research require a waiver of the requirement for written documentation of informed consent? 
    NA
J2.  Consent Procedures 
Who will recruit subjects for this study? 
    PI 
PI's staff
Describe how research population will be identified, recruitment procedures, any waiting period between informing 
the prospective participant and obtaining consent, steps taken to minimize the possibility of coercion or undue 
influence and consent procedures in detail. 
    
The PI or approved collaborators as listed in this protocol will recruit patients that will be undergoing 
procedures for which a caudal block will already be provided as standard of care. Consent for the anesthetic 
including the caudal block will be taken by the attending anesthesiologist of record or designated associate 
(resident/fellow). If inclusion/exclusion criteria are met, the PI or approved collaborators will approach the 
consenting parent for consent. The parent will be informed that no changes to their child's care will be made by 
participation in this study. They will be informed that study participation is not required and that failure to 
participate will not, in any way alter the care provided to their child. They will also be informed that consent for 
participation can be withdrawn at any time. 
Are foreign language consent forms required for this protocol? 
    Yes
 
Which of the following ways will you document informed consent in languages other than English? 
    Short-Form consent documents 

J3.  Privacy and Intrusiveness 
Will the research involve observation or intrusion in situations where the subjects would normally have an 
expectation of privacy? 
    No
J4.  Children 
Will children be enrolled in the research? 
    Yes
J5.  Neonates 
Will non-viable neonates or neonates of uncertain viability be involved in research? 
    No
J6.  Consent Capacity - Adults who lack capacity 
Will Adult subjects who lack the capacity to give informed consent be enrolled in the research? 
    No
J7.  Prisoners 
Will Prisoners be enrolled in the research? 
    No
  
Section K:  Research Related Health Information and Confidentiality 
Will research data include identifiable subject information? 
    NA
Information from health records such as diagnoses, progress notes, medications, lab or radiology findings, etc. 
    NA
Specific information concerning alcohol abuse: 
    NA
Specific information concerning drug abuse: 
    NA
Specific information concerning sickle cell anemia: 
    NA
Specific information concerning HIV: 
    NA
Specific information concerning psychiatry notes: 
    NA
Demographic information (name, D.O.B., age, gender, race, etc.): 
    NA
 
Full Social Security #: 
    NA

Partial Social Security # (Last four digits): 
    NA
Billing or financial records: 
    NA
Photographs, videotapes, and/or audiotapes of you: 
    NA
Other: 
    NA
At what institution will the physical research data be kept? 
    NA
How will such physical research data be secured? 
    NA
At what institution will the electronic research data be kept? 
    NA
Such electronic research data will be secured via BCM IT Services- provided secured network storage of 
electronic research data (Non-Portable devices only): 
    NA
Such electronic research data will be secured via Other: 
    NA
Will there be anyone besides the PI, the study staff, the IRB and the sponsor, who will have access to identifiable 
research data? 
    NA
Please describe the methods of transmission of any research data (including PHI, sensitive, and non-sensitive 
data) to sponsors and/or collaborators. 
    NA
  
Will you obtain a Certificate of Confidentiality for this study? 
    No
Please further discuss any potential confidentiality issues related to this study. 
    
The PI will de-identify all data using a random number generator to create a study number. Only the PI will 
have access to the patients medical record number which will not be shared between collaborators. this will be 
stored on a separate paper in a secured locked drawer in the secured anesthesia office at TCH 
  
Section L:  Cost/Payment 
Delineate clinical procedures from research procedures. Will subject's insurance (or subject) be responsible for 
research related costs? If so state for which items subject's insurance (or subject) will be responsible (surgery, 
device, drugs, etc). If appropriate, discuss the availability of financial counseling. 
    Standard of care will be applied No additional charges are to be acquired by the patients from participation in 
the study 

If subjects will be paid (money, gift certificates, coupons, etc.) to participate in this research project, please note 
the total dollar amount (or dollar value amount) and distribution plan (one payment, pro-rated payment, paid upon 
completion, etc) of the payment. 
Dollar Amount: 
    0
Distribution Plan: 
    N/A
  
Section M:  Genetics 
How would you classify your genetic study? 
    
Discuss the potential for psychological, social, and/or physical harm subsequent to participation in this research. 
Please discuss, considering the following areas: risks to privacy, confidentiality, insurability, employability, 
immigration status, paternity status, educational opportunities, or social stigma. 
    
Will subjects be offered any type of genetic education or counseling, and if so, who will provide the education or 
counseling and under what conditions will it be provided? If there is the possibility that a family's pedigree will be 
presented or published, please describe how you will protect family member's confidentiality? 
    
  
Section N:  Sample Collection 
None 
  
Section O:  Drug Studies 
Does the research involve the use of ANY drug* or biologic? (*A drug is defined as any substance that is used to 
elicit a pharmacologic or physiologic response whether it is for treatment or diagnostic purposes) 
    No
Does the research involve the use of ANY gene transfer agent for human gene transfer research? 
    No
O1.  Current Drugs 
  
Is this study placebo-controlled? 
    No
Will the research involve a radioactive drug that is not approved by the FDA? 
    No
  
Section P:  Device Studies 

Does this study need an IDE? 
    No
Regarding your device study, could potential harm to subjects be life-threatening? 
    No
Regarding your device study, could potential harm to subjects result in permanent impairment of a body function? 
    No
Regarding your device study, could potential harm to subjects result in permanent damage to a body structure? 
    No
  
Section Q.  Consent Form(s) 
None 
  
Section R:  Advertisements 
None