NCT04592926

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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	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.

Timeline

• Start date: 2021-04-22
• Primary completion: 2021-10-01
• Completion: 2021-12-01
• First posted: 2020-10-19
• Last updated: 2021-04-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study