Accuro Versus Traditional Landmark Palpation Technique to Determine Accurate Spinal Level for Procedures

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: identify L4/L5

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.

• Study Type: Observational
• Enrollment (Actual): 106

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Not meeting inclusion criteria

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

identify L4-5; Level marked as L4-5 using Accuro and palpation

Other: identify L4/L5; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy in identifying the L4-L5 interspace using palpation versus ultrasound imaging (3D).	whether there is a correlation between the landmark traditional technique versus US imaging. Fluoroscopy will serve a s the control (gold standard)	day one

Collaborators and Investigators

• Sponsor: University of Virginia

Publications and helpful links

General Publications

• Chin KJ, Perlas A, Chan V, Brown-Shreves D, Koshkin A, Vaishnav V. Ultrasound imaging facilitates spinal anesthesia in adults with difficult surface anatomic landmarks. Anesthesiology. 2011 Jul;115(1):94-101. doi: 10.1097/ALN.0b013e31821a8ad4.
• Vallejo MC, Phelps AL, Singh S, Orebaugh SL, Sah N. Ultrasound decreases the failed labor epidural rate in resident trainees. Int J Obstet Anesth. 2010 Oct;19(4):373-8. doi: 10.1016/j.ijoa.2010.04.002. Epub 2010 Aug 8.
• 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.
• Grau T, Leipold RW, Conradi R, Martin E. Ultrasound control for presumed difficult epidural puncture. Acta Anaesthesiol Scand. 2001 Jul;45(6):766-71. doi: 10.1034/j.1399-6576.2001.045006766.x.
• Chin KJ, Karmakar MK, Peng P. Ultrasonography of the adult thoracic and lumbar spine for central neuraxial blockade. Anesthesiology. 2011 Jun;114(6):1459-85. doi: 10.1097/ALN.0b013e318210f9f8.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: May 3, 2016
• First Submitted That Met QC Criteria: August 8, 2016
• First Posted (Estimate): August 11, 2016

Study Record Updates

• Last Update Posted (Actual): March 10, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: back pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 18684

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO