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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01243216
• Other study ID #: 1167437
• Status: Withdrawn
• Phase: N/A
• First received: November 16, 2010
• Last updated: September 29, 2016
• Start date: October 2010
• Est. completion date: August 2014

Study information

• Verified date: September 2016
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 placing labor epidurals or spinal anesthetics

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Women in labor

• Women scheduled for cesarean delivery

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Labor Pain
• Pregnancy

Intervention

Device:
• Ultrasound
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)

Locations

Country	Name	City	State
United States	Women's and Children's Hospital	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Grau T, Leipold RW, Conradi R, Martin E. Ultrasound control for presumed difficult epidural puncture. Acta Anaesthesiol Scand. 2001 Jul;45(6):766-71. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time	The time for performance of an ultrasound exam as well as the time for needle placement for labor epidurals or spinal anesthesia	30 min	No
Secondary	Patient Satisfaction	Patients will be given a questionaire grading their satisfaction on a 1 to 5 scale 1-very unsatisfied, 5-very satisfied	30 min	No