NCT01243216

Brief Summary

The investigators are interested in determining the utility of ultrasound of the spine for labor epidurals or spinal anesthesia for women in labor or having a cesarean delivery. The investigators hypothesized that in women with poor spinal landmarks that the use of ultrasound of the spine will improve the process of placing labor epidurals or spinal anesthetics

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

October 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2010

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

3.8 years

First QC Date

November 16, 2010

Last Update Submit

September 29, 2016

Conditions

PregnancyLabor Pain

Keywords

PregnancyLaborEpidural AnalgesiaEpidural AnesthesiaSpinal AnesthesiaUltrasoundNeuraxial AnalgesiaNeuraxial AnesthesiaCesarean delivery

Outcome Measures

Primary Outcomes (1)

  • Number of attempts needed for proper needle placement

    An attempt is defined as a separate needle puncture. A needle pass is defined as the passage of a needle through a single puncture site

    30 min or less

Secondary Outcomes (2)

  • Time

    30 min

  • Patient Satisfaction

    30 min

Study Arms (2)

Ultrasound Group

EXPERIMENTAL

Patients in the Ultrasound Group will have a pre-procedure ultrasound of the spine prior to needle placement

Device: Ultrasound

No Ultrasound Group

NO INTERVENTION

Patients in the No Ultrasound Group will not have a pre-procedure ultrasound of the spine performed prior to needle placement.

Interventions

UltrasoundDEVICE

Ultrasound examination of the lumbar spine. The level of the lumbar interspace will be determined by the oblique/sagittal method. The transverse method will be used to determine the best lumbar interspace and the distance from the skin to the target (epidural space or intrathecal space)

Ultrasound Group

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women in labor
  • Women scheduled for cesarean delivery

You may not qualify if:

  • Under age 18
  • Emergency cesarean deliveries
  • Unable to cooperate with ultrasound examination or regional anesthesia
  • Advanced labor
  • Contraindications to regional anesthesia
  • Unable to understand the consent process

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's and Children's Hospital

Columbia, Missouri, 65201, United States

Location

Related Publications (5)

  • Carvalho JC. Ultrasound-facilitated epidurals and spinals in obstetrics. Anesthesiol Clin. 2008 Mar;26(1):145-58, vii-viii. doi: 10.1016/j.anclin.2007.11.007.

    PMID: 18319185BACKGROUND

  • Arzola C, Davies S, Rofaeel A, Carvalho JC. Ultrasound using the transverse approach to the lumbar spine provides reliable landmarks for labor epidurals. Anesth Analg. 2007 May;104(5):1188-92, tables of contents. doi: 10.1213/01.ane.0000250912.66057.41.

    PMID: 17456672BACKGROUND

  • Chin KJ, Perlas A, Singh M, Arzola C, Prasad A, Chan V, Brull R. An ultrasound-assisted approach facilitates spinal anesthesia for total joint arthroplasty. Can J Anaesth. 2009 Sep;56(9):643-50. doi: 10.1007/s12630-009-9132-8. Epub 2009 Jun 23.

    PMID: 19548051BACKGROUND

  • Grau T, Bartusseck E, Conradi R, Martin E, Motsch J. Ultrasound imaging improves learning curves in obstetric epidural anesthesia: a preliminary study. Can J Anaesth. 2003 Dec;50(10):1047-50. doi: 10.1007/BF03018371.

    PMID: 14656785BACKGROUND

  • Grau T, Leipold RW, Conradi R, Martin E. Ultrasound control for presumed difficult epidural puncture. Acta Anaesthesiol Scand. 2001 Jul;45(6):766-71. doi: 10.1034/j.1399-6576.2001.045006766.x.

    PMID: 11421838BACKGROUND

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

Study Officials

  • Steven T Fogel, M.D.

    University of Missouri-Columbia School of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2010

First Posted

November 18, 2010

Study Start

October 1, 2010

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

September 30, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)