The Impact of Pre-Insertion Ultrasound for Lateral-Position Spinal in Cesarean Delivery: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Number of Needle Redirections
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
The patient and observer who collects the outcome data will be blinded to group allocation. The anesthesiologist caring for the patient and the resident/fellow performing the spinal anesthetic will be unblinded.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Accuro ultrasound
Intervention: Accuro SpineNav3D (Device)
Control
Intervention: Sham (Other)
Outcomes
Primary Outcomes
Number of Needle Redirections
Time Frame: through study completion, average of 3 hours
Number of times the angle of the spinal introducer needle is adjusted, without exiting and re-entering the skin
Secondary Outcomes
- Procedural Time(through study completion, average of 3 hours)
- Number of Needle Passes(through study completion, average of 3 hours)
- Patient Satisfaction with procedure(through study completion, average of 3 hours)
Investigators
Naida Margaret Cole
Staff Anesthesiologist, Principal Investigator
Brigham and Women's Hospital