Evaluation the Impact of the "Pas" Technique Versus the "Standard" Technique on Radiation Exposure, Procedure Efficiency, and Patient Outcome in Pain Management Injections
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 212
- Locations
- 1
- Primary Endpoint
- Radiation Exposure
Study Overview
Brief 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
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •**Inclusion Criteria:**
- •Adult patients aged 19 and older
- •No history of:
- •Convictions
- •Infections
- •Contraindications for surgical procedures
- •Patients scheduled for pain injections who:
- •Agree to participate in the study
- •Sign informed consent and IRB approval consent
- •Complete preoperative, postoperative, and 1-week postoperative questionnaires
- •Patients with chronic lower back pain (lasting over three months) that has not responded to conventional treatments (e.g., NSAIDs, back muscle strengthening, physiotherapy)
- •Symptoms indicating facet pain, including:
- •Lower back pain with or without radiation to the buttocks, thigh, or groin
- •Pain increasing on hyperextension
- •Pain during initial movements
- •Focal tenderness over the facet joint when pressed
- •Post-lumbar disc surgery patients with persistent pain but no MRI evidence of arachnoiditis or infection
- •All procedures conducted under fluoroscopic guidance for spinal needle placement
- •Data collection parameters:
- •Gender, race, height, weight, BMI
- •Radiation exposure from fluoroscopy dosage logbook
- •Procedure time
- •Horizontal and longitudinal distance measurements between spinal levels (in cm)
- •Study period: October 1, 2023, to May 15, 2024
Exclusion Criteria
- •Evidence of:
- •Infection (elevated WBC >12,000 or UTI)
- •Neoplastic disease
- •Possible pregnancy, bleeding diathesis, or anticoagulant therapy
- •History of sensitivity to local anesthetics
- •**Preoperative and Postoperative Assessments:**
- •Visual Analog Scale (VAS)
- •Numeric Pain Scale
- •Disability Oswestry Index questionnaires
- •Additional data collection for both cohorts:
- •Patient demographics (age, gender, race, height, weight, BMI)
- •Radiation exposure from fluoroscopy (in mGy)
- •Procedure duration
- •Horizontal and vertical distance measurements (in cm) between spinal needle placements
Arms & Interventions
Standard Technique
Standard Technique is the standard protocol for the pain management procedures completed in this study such as Medical Branch Block, Radiofrequency Ablation, Sacroiliac Joint Block, and Transforaminal Epidural
Intervention: Standard Technique (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.
Intervention: PAS Technique (Procedure)
Outcomes
Primary Outcomes
Radiation Exposure
Time Frame: During the index procedure (from first fluoroscopy activation to last activation on Day 0; ≤ 20 min)
radiation exposure from the fluoroscopy dosage logbook
Procedure length in time
Time Frame: During the index procedure (from anesthesia induction to application of the final bandage after injection on Day 0; measured in minutes)
Total Procedure Time
Radiation Exposure
Time Frame: through study completion, an average of 6 months
Examined Radiation Exposure amount from Fluoroscopic Guidance on Patient
Secondary Outcomes
- Numeric Pain Scale(through study completion, an average of 6 months)
Investigators
Gabriel Garcia-Diaz
Orthopedic Spinal Surgeon, Principal Investigator
Mercy Medical Center