Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02271100 |
| Other study ID # |
2014P000267 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 25, 2016 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
May 2021 |
| Source |
Beth Israel Deaconess Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study is intended to determine whether ultrasound imaging can improve the ability to
place a spinal or epidural needle in obstetric anesthesia. By evaluating the use of
ultrasound for the placement of epidural catheters the investigators hope to answer two
questions:
1. How does the traditional technique based on palpation compare to one using ultrasound to
place an epidural catheter? 2. Does ultrasound reduce one potential risk in epidural
placement?
Description:
This study contains two phases:
1. A prospective, randomized, blinded comparison of ultrasound imaging versus palpation for
epidural catheter insertion in laboring women.
2. A prospective, single cohort, blinded trial to assess whether ultrasound imaging
provides a reliable placement below the L3 vertebra.
The initial phase of the investigation will be a randomized comparison of ultrasound versus
palpation. Patients will be enrolled in early labor and will be randomized to have their
epidural placed with either technique. The technique will be chosen by computer-generated
randomization list maintained in opaque sequentially numbered envelopes. Description of the
placement technique is below. The primary outcome will be the number of epidural catheters
inserted above the intended insertion site. The investigators will also assess the total time
required for epidural catheter placement, number of attempts for successful insertion,
effectiveness of the epidural catheter for labor pain control.
Following completion of enrollment of the first phase, the second phase of the investigation
will enroll patients only into the single-cohort ultrasound arm. The study will use the same
methodology as the initial phase, but without randomization due to a single cohort. The
primary outcome will be the absolute number of epidural catheters inserted above the L3
vertebral body. The investigators will also assess the effectiveness of the ultrasound
markings for guiding placement.
Procedure placement technique After written, informed consent, and standard patient
preparation, the epidural catheter will be placed with the patient in the sitting position by
a junior resident. In the ultrasound arm, the patient will be first imaged using an
appropriate probe, and the identified ultrasound landmarks marked on the skin. The skin will
be prepped in the usual fashion, and the needle will be inserted at the identified site and
direction determined by ultrasound. In the palpation arm, the skin will be prepped and the
needle will be inserted using palpation-identified landmarks to guide the needle. All
catheters will be intended to be placed at the L4-L5 interspace as the primary attempt. The
L3-L4 interspace will be used as a secondary attempt.
Assessment of final position After insertion of the epidural catheter and administration of
the pain relief medication, patients in both groups will be examined by a blinded observer
using ultrasound to determine the catheter insertion site and the likely insertion
interspace.
If, however, the investigators discover that the use of ultrasound for placement of the
epidural catheter may present greater risk than previously anticipated to the pregnant woman
or fetus, then the investigators will stop the study after phase 1 and not proceed with phase
2.
