Comparative Analysis of Force and Pressure Requirements Across Different Syringe Sizes for Pain Management Procedures: A Randomized Prospective in Vivo Trial

This was a randomized prospective double-blind 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# 2023-100). Subject confidentiality and privacy were protected according to the Health Insurance Portability and Accountability Act (HIPAA). The research study included all voluntary patients undergoing pain management procedures from October 1, 2023 to May 15, 2024. Patients were asked about their interest in voluntarily participating in the research study. Interested patients were taken to another conference room by research staff, where the study was explained in detail, and they were given written information with enough time to consider the alternatives, risks, and benefits of participating in the research project.

Patients requiring more time to sign the informed consent or needing additional time to read the information or ask questions about the study were offered more time to decide from registration until they reached the preoperative area. In the preoperative area, research staff asked patients to confirm their decision to participate in the research project and addressed any further questions. Patients were given written information in English or Spanish, including a short form with an attestation in lay-person terminology regarding the research project and questions clarification. Basic information about the data collected and HIPAA privacy was also provided. Patients were asked to sign informed consent for enrollment into the study. All procedures were performed by one orthopedic spine surgeon Dr. Gabriel Garcia-Diaz who conducted all spinal pain injections for pain management procedures at the University Surgery Center, Merced, CA. Data was collected by Ahmadzakaria Arjmand, Ahmed Zabiba, and Ahmadzaki Arjmand.

Patients with cervical, thoracic, and lumbosacral pain from a single surgical practice, OrthoSpine Advance Health, Inc., were enrolled. Procedures were performed at the outpatient University Surgery Outpatient Center. Patients were initially assessed by a single orthopedic spine surgeon with more than ten years of experience performing pain management procedures and over 12,000 interventional pain injections. The patients' procedures were ambulatory, with patients fasting, off blood thinners, and under monitored anesthesia care (MAC) by a licensed anesthesiologist or certified CRNA, followed up one week after the procedure.

All patients undergoing procedures from October 1, 2023 to May 15, 2024, were asked about their interest in participating in the research study. Interested patients were taken to another conference room by research staff, where the study was explained in detail, and they were given enough time to consider the alternatives, risks, and benefits of participation. If patients needed more time to read the information or ask more questions, they were offered additional time to decide from registration until they reached the preoperative area. In the preoperative area, patients were asked by research staff to confirm their decision to participate in the research project and address any remaining questions. After deciding to participate, patients were assigned a User ID, which was added to the assigned official injection list from the University Surgery Center for cross-reference. This process ensured that only participating patients with User IDs were included in the official procedure list without identifying patient information in the general data collection sheet.

After assigning the User ID, patients were stratified based on the procedure to be performed. Patients were categorized into groups depending on the procedure: Category I for sacroiliac joint blocks, Category II for transforaminal injection blocks (T-thoracic, L-lumbar), Category III for medial branch blocks (C-cervical, T-thoracic, L-lumbar), and Category IV for radiofrequency ablation (C-cervical, T-thoracic, L-lumbar). Each category was randomly distributed into four cohort groups (A, B, C, D) for each syringe size (5ml, 10ml, 20ml, 30ml). The syringes and needles used during the procedures were manufactured by BD, McKesson, or Stryker (Table 1).