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Evaluation the Impact of the "Pas" Technique Versus the "Standard" Technique on Radiation Exposure

NCT06918197 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2025-04-09

No results posted yet for this study

Summary

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

Conditions

  • Spine
  • Fluoroscopy for Spine Surgery
  • Back Pain
  • Sacroiliac Joint

Interventions

PROCEDURE

PAS Technique

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.

PROCEDURE

Standard Technique

In the "Standard" or "Traditional "technique, the spinal needles are used to localize the anatomical objective using fluoroscopic guidance for each needle placement. Traditionally, each needle is placed individually with a spot radiological view before placement and after placement of each needle to confirm the localization.

Sponsors & Collaborators

  • Orthospine Advance Health, Inc.

    lead OTHER

Principal Investigators

  • Mary Oster, Metrowest IRB Chair · Metro West Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2024-05-15
Completion
2024-05-15

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06918197 on ClinicalTrials.gov