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Evaluation the Impact of the "Pas" Technique Versus the "Standard" Technique on Radiation Exposure, Procedure Efficiency, and Patient Outcome in Pain Management Injections
The purpose of this study is to compare both techniques and analyze the data from the "Standard" technique to help design the "PAS" technique. In the "PAS" technique, investigators predetermine the distances from the needles and place them all together using our initial target needle marker in the objective anatomic landmark. Will randomized patients assigning them either in cohort 1 control "Standard" of care technique and cohort 2 "PAS" technique. After only utilizing the "Standard" of care technique, will obtain the measurements and distances from the needles inserted in patients under fluoroscopic guidance for the different pain procedures. The data will help demonstrate that is possible to predict the needle placement replicating with confidence good outcomes using the "PAS" technique to reduce the radiation exposure and time. Our data will justify the use of the "PAS" technique to become an alternative to the "Standard" of care technique for a faster, efficient, and replicable needle placement for diminished radiation exposure, to avoid complications and consistent good outcomes
PAS Technique Protocol: The following steps outline the PAS Technique. While the example below uses 6 injection sites, the approach can be adapted for different pain management procedures with a different number of needle injection sites as needed. Timer: Begin stopwatch for entire procedure from start to medication insertion. Positioning: The patient is placed in a prone position on the fluoroscopic table. Time out was performed. Skin Preparation: Clean the injection site with an antiseptic solution and drape it to maintain sterility. Anesthesia: Administer intravenous sedation Identification of Anatomical Landmark:The spinous process was located and marked as the reference point (SP), which was then used as a guide for the following steps. Marking Target Points: Using the spinous process (SP) as the anatomical landmark and X-ray guided fluoroscopy, Target Point 1 (TP1) was identified and its position verified. The X value (the horizontal distance from the SP to TP1) was measured. This X value was not just a guide but the exact horizontal distance used for the placement of all subsequent target points. For the vertical distance between target points, a consistent distance of 3 cm was applied. This value was determined as the average vertical distance between the target points based on prior findings. Refer to Figure 2 for a detailed illustration of the target point positions in relation to the spinous process and the distances applied. Horizontal Distance (X Values): The X value represents the horizontal distance from the spinous process (SP) to each target point (TP). The X value measured for TP1 was used as the fixed horizontal distance for all target points on both sides of the SP. For target points on the opposite side of the SP, the same X value was mirrored. Thus, for the entire procedure: TP1 and TP4 were placed at an equal X distance to the right and left of the SP, respectively. TP2 and TP5 followed the same X distance as TP1 and TP4, located on their respective sides of the SP. Vertical Distance (Y Values): The Y value represents the vertical distance between the target points. A consistent vertical distance was applied between the target points. This was determined as the average distance between the target points based on prior findings. Therefore: TP2 was positioned 3 cm below TP1. TP3 was positioned 3 cm above TP1. TP5 was positioned 3 cm below TP4. TP6 was positioned 3 cm above TP4. Final Verification: One final fluoroscopic image was taken to verify the accurate placement of all needles at the marked target points.
Age
19 - No limit years
Sex
ALL
Healthy Volunteers
No
University Surgery Center
Merced, California, United States
Start Date
October 1, 2023
Primary Completion Date
May 15, 2024
Completion Date
May 15, 2024
Last Updated
April 9, 2025
212
ACTUAL participants
PAS Technique
PROCEDURE
Standard Technique
PROCEDURE
Lead Sponsor
Orthospine Advance Health, Inc.
NCT07478289
NCT06528288
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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View ClinicalTrials.gov Terms and ConditionsNCT07461636