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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02862964
• Other study ID #: 18684
• Status: Completed
• Start date: February 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: March 2022
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Not meeting inclusion criteria

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
United States	University of Virginia Health System	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. Review. — View Citation

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. — View 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. — View Citation

Grau T, Leipold RW, Conradi R, Martin E. Ultrasound control for presumed difficult epidural puncture. Acta Anaesthesiol Scand. 2001 Jul;45(6):766-71. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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