Utilizing Ultrasound for Residents as an Aid in Epidural Placement

Study Overview
=================
Brief Summary
-----------------
This randomized controlled trial will evaluate the use of ultrasound as an aid for epidural placement in residents performing all epidural techniques under direct staff anesthesiologist supervision.

Detailed Description
-----------------
The purpose of this study is to assess the abilities of the Accuro to assist in lumbar epidural placement in patients. It is hypothesized that the use of the Accuro will result in an increase of first-attempt success rates, defined as successful epidural needle placement on the first needle insertion attempt.

Official Title
-----------------
Utilizing Ultrasound for Residents as an Aid in Epidural Placement

Conditions
-----------------
Epidural Placement

Intervention / Treatment
-----------------
* Device: Ultrasound Guided Epidural
* Procedure: Standard Epidural


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting for vaginal delivery ASA-1, ASA-2, and ASA-3 Patients with no known back deformities Ability to sit upright for epidural placement No prior lumbar surgery No allergies to ultrasound gel Pre-pregnancy BMI >= 30 Exclusion Criteria: Patients < 18 years of age

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Epidural<br>Participants in this group will have epidurals placed using standard practice. | Procedure: Standard Epidural<br>* The point of needle entry will be located using the landmarks technique. The specific level of epidural placement will be determined on a per-patient basis at the anesthesiologist's discretion. The spine midline will also be palpated to determine the approximate location of an interlaminar space. The needle will then be inserted at the appropriate location determined by the landmarks technique, and successful epidural placement will be confirmed by observation of loss of resistance and follow-up confirmation of analgesia. The depth of the epidural needle placement will be measured and recorded following observation of loss of resistance. The epidural catheter will be inserted and the procedure will continue according to the standard of care.<br>|
| Experimental: Ultrasound Guided Epidural<br>Participants in this group will have epidurals placed using standard practice with the assistance of ultrasound. | Device: Ultrasound Guided Epidural<br>* Sterile ultrasound gel will be applied to the patient's back and the sterile device will be used to image the lumbar vertebrae in the area of the palpation-derived location. When the device is placed above the vertebral interspace, the 3D image mode will identify the spine midline and the depth from the skin to the epidural space. A single 3D ultrasound video loop of the vertebral interspace will be saved to confirm correct landmark identification. After identification of the vertebral interspace, the skin will be marked with a marking utensil or physical indentation at the point of needle entry indicated by the device. The epidural needle will then be placed in the same fashion as in the standard procedure group. The depth of the epidural needle placement will be measured and recorded following observation of loss of resistance.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success Rate | Success rates are defined as successful epidural administration on the first needle insertion attempt. This outcome will be a dichotomous (yes/no) outcome. | Baseline (at time of procedure) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Needle passes | A needle pass is defined as any forward advancement or withdraw and forward redirection of the needle without withdraw from the skin. This outcome will capture the number of passes. | Baseline (at time of procedure) | 
| Needle insertion attempts | The number of needle insertion attempts is defined as advancement of the needle through the skin in an effort to enter the epidural space; a needle requiring withdrawal from the skin for reinsertion is to be counted as an additional insertion attempt. | Baseline (at time of procedure) | 
| Accuracy of needle insertion | The accuracy of needle insertion location is determined by the need to redirect (different angle) or reinsert the needle (different skin puncture site). This outcome will describe qualitatively the accuracy of the needle placement. | Baseline (at time of procedure) | 
| Vertebral level of epidural placement | Vertebral level of epidural placement is a record of the vertebral level where the epidural is administered. This will be confirmed via ultrasound imaging in both standard group and ultrasound group following epidural administration. | Baseline (at time of procedure) | 
| Time to landmark identification | Time to landmark identification is defined as the time interval between the start of needle puncture site identification and the time to first needle puncture attempt. The start time of needle puncture site identification in both the standard group and ultrasound group corresponds to when the resident physician first places his/her hand on the patient to palpate the back. | Baseline (at time of procedure) | 
| Time to loss of resistance | Time to loss of resistance is defined as the time interval between the first needle puncture attempt and the observation of loss of resistance. | Baseline (at time of procedure) | 
| Time to complete epidural analgesia administration | Time to complete epidural analgesia administration is defined as the time interval between the observation of loss of resistance and administration of analgesics through the epidural catheter. | Baseline (at time of procedure) | 
| Total technical procedure time | Total technical procedure time is defined as the sum of (iv) Time to landmark identification, (v) Time to loss of resistance, and (vi) Time to complete epidural analgesia administration. This technical procedure time measure the time between first placing hands on the patient to the administration of analgesia. | Baseline (at time of procedure) | 
| Epidural space depth | Epidural space depth is the depth from the skin to the epidural space as measured in centimeters (accurate to 0.1 cm). | Baseline (at time of procedure) | 
| Pain | Pain during epidural administration: to be assessed after the completion of catheter insertion (verbal rating scale [VRS], 0-10, 0 = no pain, 10 = maximum pain). | Baseline (at time of procedure) | 
| Analgesia efficacy rate | Analgesia efficacy rate: defined as VRS <= 1 and absence of unilateral or failed block at 20 minutes after injection of the loading dose | Baseline (at time of procedure) | 
| Time to comfort | Time to comfort after administration of the loading dose will be recorded in minutes. | Baseline (at time of procedure) | 
| Patient satisfaction | Patient satisfaction with the epidural administration, assessed after the administration of the loading dose (scale 0-10, 0 = not satisfied, 10 = completely satisfied). | Follow Up (Up to 1 day) |