Clinical trial NCT03214640: Rivanna Ultrasound for Neuraxial Block
Official title: Evaluation of Success in Neuraxial Block Placement Between Using Palpation of Landmark Versus Pocket-Size Handheld Ultrasound (U/S) Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Keywords: neuraxial analgesia
spinal block
epidural block
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are 4 arms for this study--two are active comparators and two are experimental. The first arm is palpation with spinal block. The second arm is palpation with neuraxial block. The third arm is ultrasound with spinal block. The fourth arm is ultrasound with neuraxial block. Randomization is done twice - first for randomization of spinal block subjects between using palpation versus ultrasound method; and again randomization for neuraxial block (combined spinal epidural) subjects between using palpation versus ultrasound method. There will be a total of 120 planned evaluable subjects. This consists of planned evaluable randomized 60 subjects receiving spinal block for cesarean delivery (30 for palpation and 30 for ultrasound); and planned evaluable randomized 60 subjects receiving neuraxial (combined spinal epidural) block for labor analgesia.
Primary purpose: SUPPORTIVE_CARE

Brief summary: We hypothesize that the Rivanna Accuro or similar U/S device would reduce time to success of identifying epidural and/or intrathecal spaces as compared to conventional palpation method.

Detailed description: Administration of (neuraxial blocks) spinal and epidural blocks is commonly achieved by first palpating the landmarks for midline with spinous process and iliac crest for L3-4-5 intervertebral spaces. With an epidural block, a loss of resistance in a pressurized syringe is used to incrementally advance the epidural needle until identification of epidural space with loss of resistance in the pressurized syringe. With a spinal block, the spinal needle is advanced incrementally until a noted "feel" of dural puncture together with return of spinal fluid via the spinal needle. The palpation technique and somewhat "blind" technique to identify the spinal and epidural spaces become more difficult and less reliable particularly with the increasing prevalence of the morbid and super-morbid obese patients. Ultrasound devices have become common and successful with non-neuraxial blocks and venous accesses, both involving mostly non-bony, soft tissues. Application of conventional ultrasound for neuraxial blocks has been limited by its bulkiness, limited imaging for bony structures and lack of automated artificial intelligent algorithm for pattern recognition. Recent technological advancement has addressed the aforementioned limitations. Rivanna Accuro is one such device that has gained FDA approval and may have helped in addressing some of these issues. It is a handheld (pocket size) U/S device with real time pattern recognition for bony structures such as the spine while providing 3-D overlay for recognition of the midline spinous process and epidural spaces and distance. The investigators hypothesize that the Rivanna Accuro or similar U/S device would reduce time to success of identifying epidural and/or intrathecal spaces as compared to conventional palpation method. We will compare placement of neuraxial block between palpation method versus ultrasound method. We will compare placement of spinal block for cesarean delivery with palpation versus with ultrasound method, and then comparing placement of neuraxial analgeisa block (combined spinal epidural analgesia) for labor analgesia with palpation versus ultrasound method.

Eligibility criteria: Inclusion Criteria:

* BMI \>30
* Female requesting analgesia for delivery, be it via vaginal or cesarean delivery

Exclusion Criteria:

* Allergy to ultrasound gel
* Contraindication to receiving neuraxial analgesia
* Under the age of 18

Primary outcomes:
measure: Time to Success of Neuraxial Block Placement
timeFrame: 60-225 seconds
Secondary outcomes:
measure: Total Number of Needle Passes Per Placement
timeFrame: 1 hour
measure: Needle Passing Success at First Attempt
timeFrame: 1 hour
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Novant Health Forsyth Medical Center
state: North Carolina
Study officials:
affiliation: Professor, Anesthesiology
name: Peter Pan, MD, MSEE
role: PRINCIPAL_INVESTIGATOR
References: