Cesarean Section, Lumbar Ultrasound, Spinal Anesthesia
Conditions
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.
Interventions
DEVICEAccuro 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.
OTHERSham
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.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, 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.
Intervention model description
randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Needle Redirections | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Needle Passes | through study completion, average of 3 hours | Number of times the spinal introducer needle exits the skin and re-enters the skin at a new location |
| Procedural Time | through study completion, average of 3 hours | The time from subcutaneous injection of local anesthetic prior to spinal placement until the return of cerebrospinal fluid through the spinal needle is confirmed |
| Patient Satisfaction with procedure | through study completion, average of 3 hours | Patient's rating of their satisfaction with the spinal procedure using a 0-10 numeric rating scale, as measured by a blinded study investigator |
Countries
United States
Outcome results
None listed