NCT02747238

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2015

Completed
11 months until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
1.8 years until next milestone

Study Start

First participant enrolled

January 29, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 15, 2021

Completed
Last Updated

April 15, 2021

Status Verified

March 1, 2021

Enrollment Period

2.1 years

First QC Date

June 3, 2015

Results QC Date

February 24, 2021

Last Update Submit

March 20, 2021

Conditions

Pregnancy

Keywords

PregnancyEpiduralLabor

Outcome Measures

Primary Outcomes (1)

  • Learning Curve of Anesthesia Residents

    The success rate of epidural with each technique and improvement

    1 month

Secondary Outcomes (3)

  • Number of Attempts

    30 minutes

  • Percentage of Accurate Epidural Placement

    2 hours

  • Number of Angle Adjustments in Space

    30 minutes

Study Arms (2)

Ultrasound

ACTIVE COMPARATOR

Woman requests epidural for pain relief Ultrasound guided CSE placed Continuous epidural infusion started

Device: UltrasoundProcedure: Epidural infusion

No ultrasound

ACTIVE COMPARATOR

Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started

Procedure: No ultrasoundProcedure: Epidural infusion

Interventions

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.

Ultrasound
No ultrasoundPROCEDURE

Palpation of anatomical landmarks is used for placement of labor analgesia

No ultrasound
Epidural infusionPROCEDURE

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

No ultrasoundUltrasound

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount-Sinai Roosevelt Hospital

New York, New York, 10019, United States

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Results Point of Contact

Title
Dr. Barbara Orlando
Organization
Icahn School of Medicine at Mount Sinai
barbara.orlando@mountsinai.org
917-496-7490

Study Officials

  • Barbara Orlando, MD

    Mount-Sinai Roosevelt Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 3, 2015

First Posted

April 21, 2016

Study Start

January 29, 2018

Primary Completion

February 24, 2020

Study Completion

February 24, 2020

Last Updated

April 15, 2021

Results First Posted

April 15, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)