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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cesarean Section; Spinal Anesthesia; Lumbar Ultrasound
• Intervention / Treatment: Device: Accuro SpineNav3D; Other: Sham

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.

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Naida M Cole, MD; Phone Number: 617-732-5000; Email: nmcole@partners.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control	Other: Sham; 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.
Experimental: Accuro ultrasound	Device: Accuro SpineNav3D; 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.; Other Names: Accuro

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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2021
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): April 26, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2020P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no current IPD sharing plan for this data.

Drug and device information, study documents

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