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Completed

NCT Number: NCT03100968

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

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.

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Key information

Age range

19 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UAB Department of Anesthesiology and Perioperative Medicine

Birmingham, Alabama, 35249, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Palpation

Procedure

Traditional epidural methods used for the identification of the midline using palpation prior to procedure

Ultrasound

Device

Lumbar spinal ultrasound performed for identification of the midline prior to procedure.

Primary outcomes

  1. Time for Epidural Placement

    Time frame: Baseline up to 1 hour

    Comparing the time it takes for epidural placement in the palpation group vs. the ultrasound group. Measured in minutes from local anesthesia skin wheal to administration of the epidural test dose.

  2. Number of Needle Passes

    Time frame: Baseline up to 1 hour

  3. Total Time

    Time frame: Baseline up to 1 hour

Secondary outcomes

  1. Time to Identify Midline

    Time frame: Baseline up to 1 hour

    Comparing the time it takes to locate midline of the back in the palpation group vs. the ultrasound group. Measured in minutes from the start of the identification process until completion of the midline identification process.

  2. Epidural Failure Rate

    Time frame: Baseline up to 1 hour

    Comparing the number of epidural failures in the palpation vs. ultrasound group.

  3. Number of Top-offs Required

    Time frame: Baseline up to 1 hour

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Utility of Ultrasound in Identification of Midline and Placement of Epidural in Severely Obese Parturients: A Randomized, Prospective Study

Important dates

Study start
2015
Primary completion
2018
Study completion
2021
First posted
Apr 4, 2017
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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