Ultrasonography for Confirmation of Caudal Injection

NCT02321787 | Completed DMC

• 1 other identifier: IRB #2015-16004
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of our study is to evaluate whether utilizing ultrasound assessment during caudal epidural injection can reliably identify unrecognized and unsuccessful nerve blocks during the procedure, guide proper technique, and alter pain management outcome measurements for patients. Patients will be randomized to a group either undergoing caudal injection by a trainee using typical techniques or by using typical techniques in addition to ultrasound for confirmation of successful injection. The patients enrolled in this study will have the same intraoperative care, in line with the standard of care. Data will be collected intraoperatively and postoperatively on pain scores, time for performance of caudal block, and perceived success of the block. There will be no direct benefit to the patients enrolled in this study, but future patients may benefit from the use of ultrasound for the confirmation of a successful block.

Conditions

Pain, Postoperative

Keywords

Anesthesia, Caudal; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• Rate of block success in traditional group versus intervention (ultrasound) group

  Success in the ultrasonographic group will be estimated by ultrasound spread and in the traditional group by heart rate, need for additional medications, and pain scores.

  4 hours

Secondary Outcomes (1)

• Opioid Administration

  4 hours

Study Arms (2)

Traditional Methods of Assessment

NO INTERVENTION

The caudal block will be done using traditional means of assessment, not confirmed by ultrasound.

Ultrasound for Confirmation

EXPERIMENTAL

The caudal block will be performed utilizing ultrasound as an additional method of assessment for successful block (in addition to all traditional means of assessment).

Procedure: Ultrasound for confirmation of successful caudal block

Interventions

Ultrasound for confirmation of successful caudal block PROCEDURE

Use of ultrasound for confirmation of successful caudal block

Ultrasound for Confirmation

Eligibility Criteria

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

You may qualify if:

• Under the age of eight
• kg or less
• Who are undergoing lower abdominal, lower extremity orthopedic, or urological procedures in the operating room at Ann \& Robert H. Lurie Children's Hospital of Chicago (Lurie Children's) and will have a caudal epidural injection performed by an anesthesia resident physician prior to surgical incision
• Children will be the sole patient population for this study

You may not qualify if:

• Patients will be excluded if their ultrasound images are deemed inadequate for evaluation of epidural injection
• The caudal injection is abandoned after unsuccessful attempts
• The surgical incision is at or above the umbilicus

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• Northwestern University Feinberg School of Medicine: collaborator

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (7)

• Lundblad M, Lonnqvist PA, Eksborg S, Marhofer P. Segmental distribution of high-volume caudal anesthesia in neonates, infants, and toddlers as assessed by ultrasonography. Paediatr Anaesth. 2011 Feb;21(2):121-7. doi: 10.1111/j.1460-9592.2010.03485.x. Epub 2010 Dec 15.

  PMID: 21159024 BACKGROUND

• Triffterer L, Machata AM, Latzke D, Willschke H, Rebhandl W, Kimberger O, Marhofer P. Ultrasound assessment of cranial spread during caudal blockade in children: effect of the speed of injection of local anaesthetics. Br J Anaesth. 2012 Apr;108(4):670-4. doi: 10.1093/bja/aer502. Epub 2012 Feb 6.

  PMID: 22315328 BACKGROUND

• Lundblad M, Eksborg S, Lonnqvist PA. Secondary spread of caudal block as assessed by ultrasonography. Br J Anaesth. 2012 Apr;108(4):675-81. doi: 10.1093/bja/aer513. Epub 2012 Feb 6.

  PMID: 22315327 BACKGROUND

• Brenner L, Marhofer P, Kettner SC, Willschke H, Machata AM, Al-Zoraigi U, Lundblad M, Lonnqvist PA. Ultrasound assessment of cranial spread during caudal blockade in children: the effect of different volumes of local anaesthetics. Br J Anaesth. 2011 Aug;107(2):229-35. doi: 10.1093/bja/aer128. Epub 2011 Jun 3.

  PMID: 21642642 BACKGROUND

• Raghunathan K, Schwartz D, Connelly NR. Determining the accuracy of caudal needle placement in children: a comparison of the swoosh test and ultrasonography. Paediatr Anaesth. 2008 Jul;18(7):606-12. doi: 10.1111/j.1460-9592.2008.02529.x.

  PMID: 18616491 BACKGROUND

• Riccabona M. Basics, principles, techniques and modern methods in paediatric ultrasonography. Eur J Radiol. 2014 Sep;83(9):1487-94. doi: 10.1016/j.ejrad.2014.04.032. Epub 2014 May 10.

  PMID: 24932845 BACKGROUND

• Schuepfer G, Konrad C, Schmeck J, Poortmans G, Staffelbach B, Johr M. Generating a learning curve for pediatric caudal epidural blocks: an empirical evaluation of technical skills in novice and experienced anesthetists. Reg Anesth Pain Med. 2000 Jul-Aug;25(4):385-8. doi: 10.1053/rapm.2000.7590.

  PMID: 10925935 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: December 22, 2014
• Study Start: December 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 15, 2016

Record last verified: 2016-01

Locations

US (1)