Pre-Insertion Ultrasound for Lateral-Position Spinal in Cesarean Delivery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the impact of lumbar ultrasound anatomic mapping using the Accuro device on the number of needle redirections, when performing spinal anesthesia in the lateral decubitus position on patients undergoing elective cesarean delivery.

Detailed Description
-----------------
Training in neuraxial placement most commonly occurs with patients in the sitting position, since it is easy to master. However lateral placement may be preferred in emergent situations and for patient comfort. In order to provide safe and effective anesthesia to parturients, providers must be competent with the technique in both sitting and lateral positions. Ultrasound examination prior to spinal placement is a safe, non-invasive method of determining depth, midline, and interspinous location. Its use may decrease the number of needle insertions and needle passes in parturients in the sitting position, however little is known about the benefit of ultrasound use in the placement of lateral spinals. The use of lumbar ultrasound with Accuro may improve success rates, safety, and the education of residents as they learn neuraxial placement in the lateral position. This will be the first study to examine the use of Accuro for lateral neuraxial placement. The study investigators hypothesize that lumbar ultrasound with the handheld Accuro device by an experienced provider prior to spinal insertion will result in fewer needle redirections compared to palpation of landmarks when performed by anesthesia residents or fellows. The two arms of the study are as follows: Group 1: Control Group: sham pre-puncture ultrasound procedure with the handheld Accuro device turned off, followed by a sham marking on the participant's back using the Accuro locator marker attached to the device. Group 2: Ultrasound Group: pre-puncture ultrasound with Accuro followed by marking placed at the L3-4 interspace in the midline using the attached Accuro locator marker. All ultrasound exams will be performed by an unblinded physician study investigator. All study participants will have a spinal anesthetic in lateral position performed by one of the residents or fellows participating in the study.

Official Title
-----------------
The Impact of Pre-Insertion Ultrasound for Lateral-Position Spinal in Cesarean Delivery: A Randomized Controlled Trial

Conditions
-----------------
Cesarean Section, Spinal Anesthesia, Lumbar Ultrasound

Intervention / Treatment
-----------------
* Device: Accuro SpineNav3D
* Other: Sham


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women 18 years or older singleton pregnancy at least 37 weeks gestational age American Society of Anesthesiologists (ASA) Classification II body mass index (BMI) <35 kg/m2 plan for elective and scheduled cesarean section with spinal anesthesia Exclusion Criteria: patient refusal of spinal anesthesia uncorrected coagulopathy infection at the skin site of spinal placement increased intracranial pressure untreated hemodynamic instability history of scoliosis or spine surgery BMI >/=35 kg/m2 allergy to local anesthetic allergy to opioids

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Accuro ultrasound<br> | Device: Accuro SpineNav3D<br>* The intervention will consist of a pre-procedural scan of the lumbar spine using the handheld image guidance device, Accuro, to determine spinal landmarks and anticipated depth of the intrathecal space.<br>* Other names: Accuro;|
| Sham Comparator: Control<br> | Other: Sham<br>* The sham group will receive a pre-procedure sham scan (the handheld image guidance Accuro device will be placed on the back, but it will be turned off) followed by sham marking on the subject's back.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Needle Redirections | Number of times the angle of the spinal introducer needle is adjusted, without exiting and re-entering the skin | through study completion, average of 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Needle Passes | Number of times the spinal introducer needle exits the skin and re-enters the skin at a new location | through study completion, average of 3 hours | 
| Procedural Time | The time from subcutaneous injection of local anesthetic prior to spinal placement until the return of cerebrospinal fluid through the spinal needle is confirmed | through study completion, average of 3 hours | 
| Patient Satisfaction with procedure | Patient's rating of their satisfaction with the spinal procedure using a 0-10 numeric rating scale, as measured by a blinded study investigator | through study completion, average of 3 hours |