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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03100968
• Other study ID #: F150402002
• Status: Completed
• Phase: N/A
• Start date: June 22, 2015
• Est. completion date: September 2021

Study information

• Verified date: September 2021
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2021
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Epidural Anesthesia
• Obesity
• Spinal Ultrasound

Intervention

Procedure:
• Palpation
Traditional epidural methods used for the identification of the midline using palpation prior to procedure

Device:
• Ultrasound
Lumbar spinal ultrasound performed for identification of the midline prior to procedure.

Locations

Country	Name	City	State
United States	UAB Department of Anesthesiology and Perioperative Medicine	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time for Epidural Placement	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.	Baseline up to 1 hour
Primary	Number of Needle Passes		Baseline up to 1 hour
Primary	Total Time		Baseline up to 1 hour
Secondary	Time to Identify Midline	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.	Baseline up to 1 hour
Secondary	Epidural Failure Rate	Comparing the number of epidural failures in the palpation vs. ultrasound group.	Baseline up to 1 hour
Secondary	Number of Top-offs Required		Baseline up to 1 hour