Ultrasonography for Confirmation of Caudal Injection

Caudal epidural injection is the most commonly performed regional anesthetic procedure in
infants and children and is used to provide perioperative analgesia for many lower
abdominal, lower extremity, and urological procedures. Utilizing sterile technique, a needle
is advanced through the sacral hiatus and local anesthetic is injected into the epidural
space. Local anesthetic spreads cranially and results in significant sensory (+/- motor)
blockade, depending on local anesthetic concentration and volume1. Recent studies have used
ultrasound to assess cranial spread during caudal blockade, specifically evaluating how
speed of injection and different volumes can affect cranial spread2,4. Other studies have
investigated redistribution and secondary spread after initial injection of local anesthetic
by utilizing ultrasound assessment of the epidural space3.

Although no current standard exists for confirming successful caudal epidural injection,
several findings may indicate a proper needle position and can predict successful block5.
Some of these findings include: tactile appreciation of the "pop" through the sacrococcygeal
ligament, negative blood or cerebrospinal fluid aspiration, negative test dose, appropriate
resistance during injection, no subcutaneous swelling during injection, no motor or
hemodynamic response to skin incision, and no need for administration of supplemental
analgesics. Although several studies have shown that real-time ultrasound guidance can be
used during needle insertion for caudal block, this does not guarantee adequate cranial
spread and may be technically challenging for a trainee performing the block. Furthermore,
many of the tactile findings that indicate successful entry into the appropriate space can
only be appreciated by the trainee, not the supervising anesthesiologist, which complicates
supervision of this technique. At present, difficulty in reliably predicting block failure
may lead to overuse of narcotics to prevent pain in patients with potentially failed blocks
or could lead to inadequate analgesia in patients too young to reliably communicate their
pain level.

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.

The proposed study will not change the current practice with regard to patient selection for
caudal epidural injection and will not change the performance of the procedure itself. This
study may impact the practice of general pediatric anesthesiologists by providing evidence
that ultrasound is a useful tool for determining successful caudal epidural injection, may
help identify unrecognized failed blocks earlier and will evaluate which level(s) of
anesthesia training would most benefit from this assessment tool.

Patients will be randomized using pre-made folders containing an assignment to either the
control group or study group. In the study group, ultrasound will be utilized in the caudal
block to confirm placement. In the control group, the caudal block will be done without
ultrasound to assist with caudal epidural injection. In the operating room, once the
anesthesia team is prepared to begin the caudal epidural injection, the patient will be
placed in the lateral decubitus or prone position, with knees and hips flexed. The attending
for the caudal block will mark the site on the patient per the site marking policy at Lurie
Children's; this is not necessarily the attending of record for the remainder of the case.
Once the sacrum is prepped, the anesthesia provider will proceed with the caudal epidural
injection in the usual fashion. The injected solution will be 1 mL/kg of 0.2% ropivacaine
with 1:200k epinephrine, rounded up to the next mL, which is consistent with the current
standard practice at Lurie Children's. After injection of test dose (10% of the total block
volume), a one-minute pause will begin to assess for a response. During this pause, prior to
injection of the remaining dose of local anesthetic, a 13-6 MHz, linear ultrasound probe
with a sterile covering and ultrasound gel will be placed over the patient's lumbar spine,
cranial to the point of entry for the caudal block. The caudal block needle insertion site
and sterile field will be observed and undisturbed. The ultrasound probe will be positioned
paramedian along the non-dependent side of the spine, obtaining a long axis view of the
epidural and intrathecal space. The cephalad end of probe will be placed at the level of the
iliac crest. Once the ultrasound probe is positioned properly and the one-minute pause has
finished, the remaining dose of local anesthetic will be administered by the anesthesia
provider as an ultrasound clip of epidural spread is visualized.

The supervising attending anesthesiologist will be one of those listed in the personnel
form. In either group, the attending anesthesiologist will coach the resident to help guide
them to success based on the standards of care with this block. In the control group, if it
is felt that the trainee is unable to safely and successfully perform the block based on
typically utilized methods of assessment (injection pressure, needle appearance,
subcutaneous swelling) then the attending will take over the block, consistent with current
practice at Lurie Children's. In the study group, the attending will continue to use
traditional methods of assessment but will also utilize the ultrasound to assess block
success and may either take over the block at the time injection has been determined to be
unsuccessful or may redirect the trainee to success in their performance of the block.

As part of the research protocol, the primary anesthesia team should avoid giving the
patient other analgesic medications prior to the time of incision. Additionally, the
anesthesia team should have the patient at 1 MAC of sevoflurane and avoid using nitrous
oxide, at the time of incision. After incision, all anesthetic decisions will be at the
discretion of the attending anesthesiologist of record in the operating room.

Data will be collected on the level of training of the physician performing the procedure,
the proceduralist's experience level, findings during the procedure, and their confidence
level of block success. Subsequent data will be collected on response to skin incision and
need for supplemental analgesia. In the recovery room, a pain score will be assessed at the
time of phase 1 recovery discharge. Recovery room staff will be advised to only give
analgesic medications, standardized to 0.05 mg/kg of morphine, if pain is rated at > 4 on
the rFLACC scale, appropriate to the patients' age. The ultrasound probe placement, image
acquisition, survey administration, pre-incision anesthetic standardization, and recovery
room analgesic administration threshold are the only research-related procedures. All
elements of patient care described above, including withholding additional analgesics before
incision, are consistent with the current standard of care and standard practices at Lurie
Children's. The length of the study visit will be from the time of operation until PACU
discharge, with the intervention only taking place during the operation.

Caudal analgesia will be rated successful if 2 conditions are fulfilled: (1) the procedure
was performed without any physical assistance by the supervisor, with verbal comments and
suggestions allowed, and no more than 3 passes with the needle through the skin needed, and
(2) clinical success of the block. Clinical failure will be defined as need for opioid
supplementation or increased concentration of volatile anesthetic in response to clinical
signs of insufficient analgesia including increases in heart rate, blood pressure, movement
of patient, or other signs of stress at incision or during the procedure. The attending
anesthesiologist will predict whether the caudal block was successful based on clinical
indicators alone in the control group and based on ultrasound findings in the study group.
This assessment of confidence in the block must be made before emergence from anesthesia.

Inclusion Criteria:

- Under the age of eight

- 20kg 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

Exclusion Criteria:

- 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