Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02747238 |
| Other study ID # |
GCO 15-1180 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 29, 2018 |
| Est. completion date |
February 24, 2020 |
Study information
| Verified date |
March 2021 |
| Source |
Icahn School of Medicine at Mount Sinai |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The investigators believe that ultrasound guided CSE technique will help junior resident
rotating for the first time on the labor and delivery floor to place more accurately the
epidural needle in the midline position as compared to placing the epidural needle via
palpation of anatomical landmarks. This will result in increased ability to place the spinal
component with positive cerebral spinal fluid (CSF) in the spinal needle, correct midline
placement of the epidural catheter, and increase the likelihood of adequate symmetrical labor
analgesia/anesthesia.
Description:
Epidurals provide superior labor analgesia and anesthesia. Unfortunately, failure of epidural
anesthesia and analgesia is a frequent clinical problem. In a heterogeneous cohort of 2,140
surgical patients, a failure rate of 27% for lumbar epidural was described. However, the
definition of a failed epidural is broad. Different definitions include insufficient
analgesia to catheter dislodgement to conversion to general anesthesia. Epidural analgesia
failures may result from technical difficulties, insufficiencies or overdosing of local
anesthetics, epidural septum or midline adhesions, and placement of the epidural catheter
through an intervertebral foramen or into the anterior epidural space. In an imaging study of
failed epidurals, incorrect catheter placement accounted for half of the failures, while the
remaining patients experienced suboptimal analgesia through a correctly positioned catheter.
The incidence of overall failure was lower in patients receiving combined spinal-epidural
(CSE) catheters versus epidural analgesia. In one study, the CSE technique provided decreased
failure rates for labor analgesia and comparable or decreased failure rates for surgical
anesthesia, when compared with reported failure rates for epidural anesthesia. It is believed
that positive CSF flow in the spinal needle confirms correct epidural needle placement in the
epidural space and also confirms the epidural needle to be in the midline position. Placement
of the epidural needle in the midline position will minimize the incorrect placement of the
catheter to one side, providing a symmetrical analgesia versus unilateral analgesia.
However, the practice of CSE and epidural catheter placement relies on the palpation of
anatomical landmarks that are not always easy to feel. Therefore, the epidural needle maybe
placed "off midline" despite positive loss of resistance (LOR) that causes negative CSF flow
in the spinal needle and an incorrectly placed catheter. As a result, the incorrect catheter
placement will result in a "failed" or suboptimal epidural analgesia.
Ultrasound has recently been utilized to facilitate lumbar epidurals and spinals. The US
imaging of the lumbar spine in different scanning planes facilitates the identification of
the landmarks necessary for appropriate epidural space location in pregnant patients. There
are two acoustic windows that are effective for lumbar spine sonographic assessment: one seen
on the transverse approach, and the other seen on the longitudinal paramedian approach. The
ultrasound single-screen method using the transverse approach of the lumbar spine provides
reliable information regarding the landmarks required for labor epidurals. The correct
interspace and midline position are identified for correct placement of the CSE analgesia.
A previous study done by the research team, comparing "blind" vs US guidance technique. It
did not show any significant difference in term of success rate or complications with either
technique. However, the study was done by 4 trained physicians with lot of practice. At this
level of training, the investigators did not observe any technique improvement with US. Which
is why the investigators thought might have more success in showing an improvement in
technique, with junior residents rotating for the first time on the floor. The idea is to see
if there is any difference in their learning curve using the US versus the "blind" technique.
Each resident will be their own control.
