Clinical trial NCT03090295: Palpation and ACCURO for Placing Spinal in C-section
Official title: Does the Use of Both Palpation and Accuro as Compared to Palpation Alone or Use of Accuro Alone in a Single Patient Increase the First Pass Success Rate in Placing Spinals or Combined Spinal Epidurals for Cesarean Sections.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia,Obstetrical
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2017-03-24
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Accuro is a three dimensional handheld ultrasound device. This device uses sound waves to create pictures of the spine in three dimensions. This may allow the physician to view the spine in more detail for procedures such as spinal anesthesia and other diagnostic procedures.

We aim to assess the benefit of using both the Accuro and traditional landmark palpation technique to determine accurate spinal level in women who undergo cesarean section. This study will also assess provider preference for use of both Accuro and palpation compared with palpation alone or use of Accuro alone.

Anesthesia Providers will first identify the L4/L5 space using the traditional technique of palpating the iliac crests to estimate spinal level, which will be marked with a single dot from a marking pen. The provider will then use the Accuro 3000 to identify the L4/L5 interspace.

Results will be compared to results obtained in IRB 18070 "Handheld 3D lumbar spine navigation: A clinical validation study RM002" where subjects who were undergoing a C-section were randomized to either palpation or Accuro alone.


Eligibility criteria: Inclusion Criteria:

* • Patients between the ages of 18 and 45 presenting for a C-section delivery or scheduled for elective Cesarean section

  * ASA-1, ASA-2, and ASA-3
  * Patients with no known back deformities
  * Ability to sit upright for spinal placement
  * No prior lumbar surgery
  * No allergies to ultrasound gel

Exclusion Criteria:

* • Unable or unwilling to give informed consent

Primary outcomes:
measure: success rates
timeFrame: Day 1
Secondary outcomes:
measure: Level of spinal placement: a record of the vertebral level where the spinal is administered.
timeFrame: Day 1
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: University of Virginia
name: Mohamed Tiouririne, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Karmakar MK. Ultrasound for central neuroaxial blocks. Techniques in regional anesthesia and pain management 2009;13:161-70.