Clinical trial NCT02862964: Accuro Versus Traditional Landmark Palpation Technique to Determine Accurate Spinal Level for Procedures
Official title: Accuro Versus Traditional Landmark Palpation Technique to Determine Accurate Spinal Level for Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Keywords: back pain
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing any interventional pain procedure requiring the presence of an anesthesia provider under fluoroscopy at the UVA Pain Management Clinic

Brief summary: Currently, at UVA, handheld ultrasound devices (like those used to view an unborn baby) are only two dimensional. 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.

The investigators aim to assess the benefit of using the Accuro versus traditional landmark palpation technique to determine accurate spinal level for procedures. Patients who undergo interventional pain procedure per standard care under fluoroscopy and require the presence of an anesthesia provider at the UVA Pain Management Clinic will be approached for enrollment.

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 and mark this point with two dots. Participants will then be taken into the fluoroscopy suite for their scheduled procedure. Since the skin marks will not show up on fluoroscopy, and metal instrument will be laid on the skin at the interspace or interspaces that were marked using the palpation and Accuro techniques. The anesthesiology attending provider in the fluoroscopy suite will then confirm the true interspace position of these marks under fluoroscopy. It will then be recorded how many spaces off the palpation and Accuro techniques are from the intended L4/L5 level.

Detailed description: Patients who are undergoing any interventional pain procedure under fluoroscopy at the UVA Pain Management Clinic will be approached for consent.

* Each participant will sit up on the edge of the bed in the pre-procedural area of fluoroscopy.
* For each participant, a provider will first attempt to identify the L4/L5 space using the traditional technique of palpating the iliac crests to estimate spinal level. The provider will mark this space on the person's back with a single dot from a marking pen. The provider will then use the Accuro to again attempt to identify the L4/L5 interspace and mark this point with two dots.
* The participant will then be taken into the fluoroscopy suite for their scheduled procedure a metal instrument will be laid on the skin at the interspace or interspaces that were marked using the palpation and Accuro techniques. Metal instruments show up on fluoroscopy, but the skin markers will not.
* The anesthesiology attending in the fluoroscopy suite will then confirm the true interspace position of these marks under fluoroscopy performed for the standard of care procedure.
* The participant will not be exposed to any additional Fluro/ radiation time for this study
* It will then be recorded by the anesthesia provider, how many spaces off the palpation and Accuro techniques are from the intended L4/L5 level.

Eligibility criteria: Inclusion Criteria:

* An anesthesia provider under fluoroscopy at the UVA Pain Management Clinic

Exclusion Criteria:

* Not meeting inclusion criteria

Primary outcomes:
measure: Accuracy in identifying the L4-L5 interspace using palpation versus ultrasound imaging (3D).
timeFrame: day one
Secondary outcomes:
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: Grau T, Bartusseck E, Conradi R, Martin E, Motsch J. Ultrasound imaging improves learning curves in obstetric epidural anesthesia: a preliminary study. Can J Anaesth. 2003 Dec;50(10):1047-50. doi: 10.1007/BF03018371.
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