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

Study Overview
=================
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.

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

Conditions
-----------------
Epidural Anesthesia, Spinal Ultrasound, Obesity

Intervention / Treatment
-----------------
* Procedure: Palpation
* Device: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Upon enrollment into the study, participants will be randomized 1:1 to either ultrasound or palpation. Randomization will be performed via random drawing: the provider will randomly select a card assigning the method of midline identification (i.e., ultrasound or palpation). Anesthesia providers will not be randomized. Any qualified provider available to place the epidural will be the person to perform the procedure.
Masking: None (Open Label)


Arms and Interventions

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

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 |