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

Not Applicable

Completed

• Conditions: Spinal Ultrasound; Epidural Anesthesia; Obesity
• Interventions: Device: Ultrasound; Procedure: Palpation

• Registration Number: NCT03100968
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2015-06-22
• Study First Submitted: 2017-03-25
• Study First Submitted QC: 2017-03-29
• Study First Posted: 2017-04-04
• Primary Completion: 2018-10-01
• Results First Submitted: 2019-08-21
• Results First Submitted QC: 2019-09-16
• Results First Posted: 2019-09-17
• Status Verified: 2021-09
• Study Completion: 2021-09
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• patient request for a labor epidural
• BMI≥35

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound Group	Ultrasound	The ultrasound group will have an epidural placed after identifying midline with the ultrasound.
Palpation Group	Palpation	The palpation group will have an epidural placed after manual palpation of the spine.

Primary Outcome Measures

Name	Time	Method
Time for Epidural Placement	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.
Number of Needle Passes	Baseline up to 1 hour
Total Time	Baseline up to 1 hour

Secondary Outcome Measures

Name	Time	Method
Time to Identify Midline	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.
Epidural Failure Rate	Baseline up to 1 hour	Comparing the number of epidural failures in the palpation vs. ultrasound group.
Number of Top-offs Required	Baseline up to 1 hour

Trial Locations

Locations (1)

UAB Department of Anesthesiology and Perioperative Medicine; 🇺🇸 Birmingham, Alabama, United States