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PregnancyNCT01243216

Does Ultrasound of the Spine Improve Labor Epidurals/Spinal Anesthesia in Obstetric Patients?

A study testing Ultrasound in people with Pregnancy and Labor Pain, run by University of Missouri-Columbia at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy, Labor Pain
What is being tested?
Ultrasound
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Oct 2010to Aug 2014
Phase
Interventional
Are there results?
None posted in the registry

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 55 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Women in labor
  • Women scheduled for cesarean delivery

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Women's and Children's Hospital

    Columbia, Missouri, 65201

Other trials in United States

About this study

Official title: The Utility of Pre-procedure Ultrasound for Neuraxial Analgesia/Anesthesia in Obstetric Patients

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

Read the detailed description

Ultrasound has been in use for peripheral regional anesthesia for several years and is becoming more common. It is currently routinely used here at the University of Missouri. Ultrasound for neuraxial anesthesia, however, is less common and is only being done in a few centers.. There have been several case reports of its use in obstetric anesthesia for patients with prior spinal surgery or spinal deformity. There have been even few prospective randomized studies. While its use may have significant advantages, it is not yet clear what those advantages are and in whom it may be most beneficial. The investigators seek to answer the following questions regarding the use of preprocedure ultrasound for neuraxial analgesia/anesthesia in obstetric patients:

  • Are there benefits to the use of pre procedure ultrasound for neuraxial analgesia/anesthesia?
  • If so, what are the benefits?
  • If measurable, to what extent does the patient benefit?
  • Do all patients benefit or only a specific subgroup?
  • Is there a "cost" to the use of pre procedure ultrasound, i.e. extra time needed to perform the ultrasound exam vs a "savings" with the use of pre procedure ultrasound, i.e., less time to perform the epidural analgesic or spinal anesthetic as a direct result of the use of ultrasound?
  • In particular the investigators hypothesize that in patients whose spinal landmarks are not palpable or are barely palpable, ultrasound will be found to be beneficial as determined by metrics described below (see item #6). In patients whose landmarks are prominent or easily palpable pre procedure ultrasound will not be of significant benefit.
Being tested
Ultrasound
Keywords
Pregnancy, Labor, Epidural Analgesia, Epidural Anesthesia, Spinal Anesthesia, Ultrasound, Neuraxial Analgesia, Neuraxial Anesthesia, Cesarean delivery
Medical subject headings
Labor Pain

What participants receive

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

  • 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)

Study groups in NCT01243216
Study groupRoleWhat they receive
Ultrasound GroupExperimentalPatients in the Ultrasound Group will have a pre-procedure ultrasound of the spine prior to needle placement
Receives: Device: Ultrasound
No Ultrasound GroupNo interventionPatients in the No Ultrasound Group will not have a pre-procedure ultrasound of the spine performed prior to needle placement.

What is being measured

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

  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

    Measured: 30 min or less

Secondary outcomes (2)

  1. Time

    The time for performance of an ultrasound exam as well as the time for needle placement for labor epidurals or spinal anesthesia

    Measured: 30 min

  2. Patient Satisfaction

    Patients will be given a questionaire grading their satisfaction on a 1 to 5 scale 1-very unsatisfied, 5-very satisfied

    Measured: 30 min

Timeline

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

  1. First posted18 Nov 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionAug 2014
  4. Study completionAug 2014

Why it stopped: Lack of personnel/research time

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
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01243216
Sponsor's protocol ID
1167437
Status last verified
Sep 2016
First submitted
16 Nov 2010
Last updated
30 Sep 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 18319185

  • 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.

    PubMed 17456672

  • 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.

    PubMed 19548051

  • 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.

    PubMed 14656785

  • 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.

    PubMed 11421838

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound in people with Pregnancy and Labor Pain, run by University of Missouri-Columbia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of attempts needed for proper needle placement (time frame: 30 min or less). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01243216, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2016.

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