NCT02984267

Brief Summary

Placement of labor epidurals is a very common daily practice in obstetrical anesthesia. Currently, these epidurals are placed based upon palpation of landmarks to determine midline and the correct spinal level for placement. Palpation of these landmarks can be difficult, however, particularly in morbidly obese patients who have significant amounts of soft tissue overlying them. This study seeks to use ultrasound guidance to examine the spine prior to epidural placement, and see what effects this has compared to palpation alone with respect to procedure time, number of attempts, success rate in the first attempt, failure rate, complication rate, patient anxiety levels, and patient satisfaction levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2017

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 11, 2018

Completed
Last Updated

July 11, 2018

Status Verified

June 1, 2018

Enrollment Period

5 months

First QC Date

November 23, 2016

Results QC Date

March 30, 2018

Last Update Submit

June 13, 2018

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

  • Total Time Required for Epidural Catheter Placement

    Includes the time required to evaluate the spine (via ultrasound or palpation) plus the time required to successfully place the epidural catheter

    Assessed immediately during epidural catheter placement

Secondary Outcomes (9)

  • Epidural Procedure Time

    Assessed immediately during epidural catheter placement

  • Number of Attempts at Epidural Catheter Placement

    Assessed immediately during epidural catheter placement

  • Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt

    Assessed immediately during epidural catheter placement

  • Complications

    Assessed immediately during epidural catheter placement and within 24 hours after delivery

  • Epidural Failure Rate

    Assessed within 24 hours after delivery

  • +4 more secondary outcomes

Study Arms (2)

Ultrasound Group

EXPERIMENTAL

The interventional group that will have their spine evaluated by ultrasound prior to epidural placement

Device: Ultrasound

Palpation Group

OTHER

The control group that will have their epidural placed in the usual fashion based on palpation

Other: Palpation

Interventions

UltrasoundDEVICE

Using ultrasound guidance to evaluate the spine prior to epidural placement

Ultrasound Group
PalpationOTHER

Using palpation only to evaluate the spine prior to epidural placement

Palpation Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current (pregnant) BMI ≥ 40
  • Age ≥ 18
  • ASA score of 3 or less
  • Full term pregnancy (37 weeks gestational age or greater)

You may not qualify if:

  • Known scoliosis
  • Known contraindications to neuraxial blockade
  • Intrauterine fetal demise or non-viable fetus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Magee Women's Hospital

Pittsburgh, Pennsylvania, United States

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Results Point of Contact

Title
Dr. Thomas Vernon
Organization
Arizona Anesthesia Consultants
tvernon@azanesthesia.net
480-570-7082

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
OB Anesthesia Fellow

Study Record Dates

First Submitted

November 23, 2016

First Posted

December 6, 2016

Study Start

December 1, 2016

Primary Completion

April 15, 2017

Study Completion

April 15, 2017

Last Updated

July 11, 2018

Results First Posted

July 11, 2018

Record last verified: 2018-06

Locations

US(1)