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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Epidural Anesthesia; Spinal Ultrasound
• Intervention / Treatment: Procedure: Palpation; Device: Ultrasound

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • UAB Department of Anesthesiology and Perioperative Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Palpation Group; The palpation group will have an epidural placed after manual palpation of the spine.	Procedure: Palpation; Traditional epidural methods used for the identification of the midline using palpation prior to procedure
Active Comparator: Ultrasound Group; The ultrasound group will have an epidural placed after identifying midline with the ultrasound.	Device: Ultrasound; Lumbar spinal ultrasound performed for identification of the midline prior to procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of Needle Passes		Baseline up to 1 hour
Total Time		Baseline up to 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Epidural Failure Rate	Comparing the number of epidural failures in the palpation vs. ultrasound group.	Baseline up to 1 hour
Number of Top-offs Required		Baseline up to 1 hour

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2015
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: March 25, 2017
• First Submitted That Met QC Criteria: March 29, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: F150402002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes