Use of Ultrasound in Obstetric Neuraxial Analgesia and Anesthesia Data Base

NCT ID: NCT01192074

Last Updated: 2016-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-09-30

Brief Summary

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This is a data base building project on the use of pre-procedure ultrasound for the performance of labor epidural pain relief and spinal anesthesia for cesarean deliveries. Data collection includes ultrasound measured depth, actual needle depth, angle of ultrasound probe, actual needle angle, success rates, patient height and weight, number of attempts needed to place the epidural needle or spinal needle. Currently we are looking at the agreement between ultrasound determined depth of the epidural space or intrathecal space with actual needle depth.

Detailed Description

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All patients presenting in labor or are having a cesarean delivery are eligible except: patients who are under age 18, have contraindications to regional anesthesia, in advanced labor, having emergency conditions and/or unable to understand the consent process.

* Data collected include:
* Ultrasound depth in transverse and oblique sagittal views
* Actual needle depth
* Level of placement
* Number of separate needle placements
* Number of needle redirects
* Angle of probe
* Angle of needle
* Total number of attempts
* Pt height
* Pt weight
* Pt BMI
* Pt age
* Pt gravity/parity
* Pt co-morbidities, e.g. pre-eclampsia
* Procedure performed
* Operator (Attending, CA-1, CA-2, CA-3, CRNA)

What is currently being examined is the correlation between ultrasound depth of the target area vs actual needle depth

Conditions

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Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ultrasound of the spine

Pregnant women receiving labor epidural analgesia or spinal anesthesia for cesarean delivery

Ultrasound

Intervention Type DEVICE

Preprocedure ultrasound examination of the spine

Interventions

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Ultrasound

Preprocedure ultrasound examination of the spine

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Pregnant women in labor or scheduled for induction requesting labor epidural analgesia
* Pregnant women scheduled for cesarean delivery
* Pregnant women in labor who are going to have a non-emergent cesarean delivery under spinal anesthesia

Exclusion Criteria

* Emergency delivery
* Emergency cesarean section
* Advanced labor
* Contraindications to neuraxial analgesia/anesthesia
* Unable to understand consent
* Under the age of 18
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven T Fogel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

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University of Missouri Women's and Children's Hospital

Columbia, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18319185 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17456672 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19548051 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14656785 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11421838 (View on PubMed)

Other Identifiers

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1147418

Identifier Type: -

Identifier Source: org_study_id

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