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

NCT ID: NCT04592926

Last Updated: 2021-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-22
• Study Completion Date: 2021-12-01

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.

Conditions

Cesarean Section; Spinal Anesthesia; Lumbar Ultrasound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Accuro ultrasound

Group Type: EXPERIMENTAL

Accuro SpineNav3D

Intervention Type: DEVICE

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.

Control

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

Accuro

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Naida Margaret Cole

Staff Anesthesiologist, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Naida M Cole, MD

Role: primary

nmcole@partners.org

617-732-5000

Other Identifiers

2020P

Identifier Type: -

Identifier Source: org_study_id