Clinical Evaluation of the EpiFaith™ Syringe in Epidural Pain Management: A Prospective, Open-Label, Non-Randomized Comparative Study Versus Conventional Loss-of-Resistance Technique

Summary

This study evaluates a new medical device called the EpiFaith™ Syringe, which is designed to help clinicians more accurately identify the epidural space during pain management procedures. The epidural space is a narrow area near the spine where medication is delivered to treat chronic pain conditions. Finding this space correctly is a critical step in procedures such as epidural steroid injections, spinal cord stimulator placement, and minimally invasive lumbar decompression (MILD). Currently, clinicians locate the epidural space using a method called loss-of-resistance (LOR), which relies on the feel of a syringe plunger as a needle is advanced toward the epidural space. This technique depends on the clinician's experience and touch, and can sometimes result in multiple needle attempts or an incorrect signal that the epidural space has been reached when it has not. The EpiFaith™ Syringe is designed to provide a clear visual signal, called the Faith Signal, at the moment the epidural space is entered, reducing reliance on touch alone. The device is used with standard epidural needles and does not require additional equipment or significant changes to routine procedure workflow. This study will enroll 100 adults scheduled for a clinically indicated epidural pain procedure at Innovative Pain Treatment Solutions in Temecula or San Diego, California. Participants will be assigned to have their procedure performed using either the EpiFaith™ Syringe or a standard LOR syringe. The study will compare the number of needle attempts needed to access the epidural space and the rate of false signals between the two methods. Safety and patient-reported pain outcomes will also be collected for approximately one week following the procedure.

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No