Syringe Pressure Analysis: A Critical Examination of the Operator's Burden

NCT06476353 | Completed

• 1 other identifier: IRB#2023-100
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

This was a randomized prospective clinical trial conducted from October 1, 2023, to May 15, 2024, at the University Surgery Center in Merced, CA. The project was approved by the MetroWest Medical Center Institutional Review Board (IRB). Patients in each procedure group were categorized into groups and randomly distributed into four sub-groups based on the syringe size used (5ml, 10ml, 20ml, 30ml). A medical grade force sensor device was used to collect the necessary real-time syringe force data. An analysis of variance (ANOVA), and pairwise t test were used to make comparisons between means and determine statistical significance.

Conditions

Back Pain Lower Back Chronic

Keywords

Pain Management Force; Syringe Size; Pressure; Sacroiliac Joint Block; Medial Branch Block; Radiofrequency Ablation

Outcome Measures

Primary Outcomes (1)

• Measurement of Compression Force in Newtons from Syringe Plunging

  Our goal is to measure the different pressures required to administer fluid from various syringe sizes, including 5 ml, 10 ml, 20 ml, and 30 ml syringes across different pain management procedures such as sacroiliac joints, transforaminal epidural space, medial branch blocks, and radiofrequency ablation for comprehensive measurement analysis.

  During Pain Management Procedure (During Injection, 2-5 Minutes)

Secondary Outcomes (1)

• Measurement ofPressure in Pascals from Syringe Plunging

  During Pain Management Procedure (During Injection, 2-5 Minutes)

Study Arms (4)

5ml Syringe Size

EXPERIMENTAL

Analyzing the Compression Force required to plunge a 5ml Syringe during a pain management procedure.

Other: Analysis of Force and Pressure Requirements across Syringe Sizes for Pain Management Procedures

10ml Syringe

EXPERIMENTAL

Analyzing the Compression Force required to plunge a 10ml Syringe during a pain management procedure.

Other: Analysis of Force and Pressure Requirements across Syringe Sizes for Pain Management Procedures

20ml Syringe Size

EXPERIMENTAL

Analyzing the Compression Force required to plunge a 20ml Syringe during a pain management procedure.

Other: Analysis of Force and Pressure Requirements across Syringe Sizes for Pain Management Procedures

30ml Syringe Size

EXPERIMENTAL

Analyzing the Compression Force required to plunge a 30ml Syringe during a pain management procedure.

Other: Analysis of Force and Pressure Requirements across Syringe Sizes for Pain Management Procedures

Interventions

Analysis of Force and Pressure Requirements across Syringe Sizes for Pain Management Procedures OTHER

The investigators are analyzing the compression force required to plunge different syringe sizes to determine the operator's burden.

10ml Syringe; 20ml Syringe Size; 30ml Syringe Size; 5ml Syringe Size

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients 19 years old and older, no convicts, no prior history of infection, cancer, or contraindications for surgical procedures.
• Patients scheduled for pain injections who agree to participate in the study, sign the informed consent, IRB approval consent, and agree to answer preoperative, postoperative, and 1-week postoperative questionnaires.
• Patients with chronic lower back pain for over three months, not responding to conventional treatment, including NSAID drugs, core back muscle strengthening with lower back exercises or physiotherapy.
• Symptoms suggestive of facet pain (e.g., LBP with or without radiation to the buttocks, thigh, or groin; pain increasing on hyperextension; pain when initiating movement) scheduled for medial branch blocks and radiofrequency injections when indicated, with focal tenderness over the facet joint elicited by digital pressure.
• Post-lumbar disc surgery patients with persistent pain and no MRI evidence of arachnoiditis or infection.
• For all pain procedures, fluoroscopic guidance will be utilized for spinal needle placements.
• Data collection will include gender, race, height, weight, BMI, radiation exposure from the fluoroscopy dosage logbook, procedure time, horizontal distance measurement between the same spinal level in centimeters (interspinous-same spinal level), and longitudinal distance measurement from needles (adjacent spinal level).
• The study period is from October 1, 2023, to May 15, 2024.

You may not qualify if:

• Clinical or imaging evidence of infection (elevated WBC 12000 or UTI) or neoplastic disease.
• Possible pregnancy, bleeding diathesis, or anticoagulant therapy.
• History of sensitivity to local anesthetics.
• Potential Failures: if we encounter any technical failure or unreliable no readings with the equipment obtaining the injection peak force curve, will exclude those readings (NA).
• Data Collection for Both Cohort Groups:
• \- Gender, age, height (inches), weight (kg), BMI, time from the start of the procedure until the end of needle placement.

Sponsors & Collaborators

• Orthospine Advance Health, Inc.: lead

Study Sites (1)

University Surgery Center

Merced, California, 95340, United States

Location

Study Officials

• Gabriel Garcia-Diaz, MD

  Orthospine Advance Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 26, 2024
• Study Start: October 1, 2023
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)