An interventional study of Accuro SpineNav3D and Sham in Cesarean Section, Spinal Anesthesia and Lumbar Ultrasound, sponsored by Brigham and Women's Hospital. Status unknown at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-26.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Diagnostic
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.
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.
Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Accuro SpineNav3D
Other: Sham
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.
Also known as: Accuro
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.
Number of Needle Redirections
Number of times the angle of the spinal introducer needle is adjusted, without exiting and re-entering the skin
Time frame: through study completion, average of 3 hours
Number of Needle Passes
Number of times the spinal introducer needle exits the skin and re-enters the skin at a new location
Time frame: 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
Time frame: 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
Time frame: through study completion, average of 3 hours
Plan to share: No — There is no current IPD sharing plan for this data.
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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