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Utility of Ultrasound in Identification of Midline and Placement of Epidural in Severely Obese Parturients

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Completed

Conditions

Epidural Anesthesia
Obesity
Spinal Ultrasound

Treatments

Procedure: Palpation
Device: Ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT03100968
F150402002

Details and patient eligibility

About

This study will address the utility of ultrasound in the placement of an epidural catheter in severely obese parturients. Identification of midline can often be difficult using the standard method of palpation in obese patients. The Investigator will determine if the use of ultrasound decreases the amount of time and number of attempts required to place the epidural.

Full description

The use of ultrasound has expanded into many areas of medicine including the identification of bony landmarks to facilitate epidural placement in obstetric anesthesia. Using ultrasound for epidural placement has become popular over the last decade with several studies being published on the topic. The likely increase in popularity for ultrasound use in the obstetric population is the need to more reliably locate bony landmarks as the traditional palpation technique has been shown to be an inaccurate way to accomplish this. Given the fact that the long-taught palpation technique can be inaccurate and studies have validated the use of ultrasound for epidural placement, ultrasound technique is routinely taught by the obstetric anesthesiologists to the anesthesiology residents at the University of Alabama at Birmingham (UAB). Also, since both techniques are considered standard practice at UAB, anesthesia providers (residents, fellows, and faculty) are free to choose either technique to locate bony structures of the back prior to epidural placement. Since no current study has specifically addressed its use in the obese pregnant patient, the investigators would like to validate its use in this population.

In this study, investigators will evaluate the use of ultrasound in the obese population to determine if its use will decrease the time it takes to place the epidural and number of attempts required when compared to the traditional palpation technique. The study will also determine the success rate of epidural placement in both the palpation and ultrasound groups.

Enrollment

150 patients

Sex

Female

Ages

19 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • patient request for a labor epidural
  • BMI≥35

Exclusion criteria

  • BMI<35
  • patient refusal of a labor epidural
  • coagulopathy
  • platelets<80,000
  • prior spine procedure or instrumentation
  • a diagnosis of scoliosis
  • an intracranial or spinal mass

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

Palpation Group
Active Comparator group
Description:
The palpation group will have an epidural placed after manual palpation of the spine.
Treatment:
Procedure: Palpation
Ultrasound Group
Active Comparator group
Description:
The ultrasound group will have an epidural placed after identifying midline with the ultrasound.
Treatment:
Device: Ultrasound

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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