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PregnancyNCT02747238

Does Ultrasound Help Junior Anesthesia Residents With Placement of Labor Analgesia in Pregnant Patients

A study testing Ultrasound, No ultrasound and Epidural infusion in people with Pregnancy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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. Read more about this study

Who is it for?
Ages 18 to 48 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy
What is being tested?
Ultrasound, No ultrasound and Epidural infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
29 Jan 2018to 24 Feb 2020
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 48 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Nulliparous
  • Term (>37 weeks gestation)
  • Vertex presentation
  • Singleton gestation
  • Ability to provide informed consent
  • Request for analgesia for labor pain
  • Maternal age 18 years or greater

Who cannot join

  • Multiparous
  • Preterm (< 37 weeks gestation)
  • Presentation other than vertex (breech, transverse)
  • Active drug/alcohol dependence
  • Previous spinal surgeries
  • Known spinal deformities

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Mount-Sinai Roosevelt Hospital

    New York, New York, 10019

Other trials in United States

About this study

Official title: Does Ultrasound-guided CSE Technique Improve Midline Placement of Epidural Needle Thereby Helping Junior Residents With Correct Placement of the Catheter Compared to the Placement Using With Anatomical Landmarks?

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.

Read the detailed 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.

Conditions
Pregnancy
Being tested
Ultrasound, No ultrasound, Epidural infusion
Keywords
Pregnancy, Epidural, Labor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UltrasoundDevice

    The ultrasound 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.

  • No ultrasoundProcedure or surgery

    Palpation of anatomical landmarks is used for placement of labor analgesia

  • Epidural infusionProcedure or surgery

    An epidural infusion will be started in both groups, regarding of the technique used for placement, and the same solution of Bupivacaine 0.0625% with 2mcg fentanyl/cc will be used in both groups

Study groups in NCT02747238
Study groupRoleWhat they receive
UltrasoundActive comparatorWoman requests epidural for pain relief Ultrasound guided CSE placed Continuous epidural infusion started
Receives: Device: Ultrasound; Procedure: Epidural infusion
No ultrasoundActive comparatorPalpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started
Receives: Procedure: No ultrasound; Procedure: Epidural infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Learning Curve of Anesthesia Residents

    The success rate of epidural with each technique and improvement

    Measured: 1 month

Secondary outcomes (3)
  1. Number of Attempts

    The number of attempts to locate the epidural space and midline position via ultrasound guided CSE technique.

    Measured: 30 minutes

  2. Percentage of Accurate Epidural Placement

    Percentage of accurate epidural placement assessed by participant reporting pain 2 hours after CSE placed

    Measured: 2 hours

  3. Number of Angle Adjustments in Space

    The number of angle adjustments of the epidural needle via ultrasound guided CSE technique.

    Measured: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2016 (estimated)
  2. Study start29 Jan 2018
  3. Primary completion24 Feb 2020
  4. Study completion24 Feb 2020

Why it stopped: lack of enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02747238
Sponsor's protocol ID
GCO 15-1180
Status last verified
Mar 2021
First submitted
3 Jun 2015
Last updated
15 Apr 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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