Pilot Study Evaluating the Lumoptik BrightPoint Device as a Secondary Confirmation Tool for Loss of Resistance in Lumbar Epidural Procedures

What this Trial Is About

Researchers are evaluating the BrightPoint Epidural device, a new system using multispectral reflectometry, to assist in lumbar neuraxial procedures requiring an epidural needle. This device aims to provide a secondary confirmation of the Loss of Resistance LOR technique and to serve as a training tool for teaching lumbar epidural placement. The study intends to improve current practices by potentially reducing complications like dural punctures and misplaced epidurals, especially during training. Participants will undergo lumbar neuraxial procedures performed by trained anesthesiologists who use the BrightPoint device alongside the standard LOR technique with saline. The device is connected between a standard epidural needle and a saline-filled syringe, providing real-time visual feedback to the anesthesiologist during the procedure. The LOR technique remains the primary confirmation method, while the devices graphic and color display serves as a secondary confirmation. During the study, researchers will observe the procedure and evaluate clinical opinions on the devices usefulness. They will measure real-time confirmation of epidural space access, the time taken to insert the needle and identify the epidural space, and the success rate of neuraxial procedures. Assessments occur after surgery completion, and the study includes patients aged 18 to 99 undergoing lumbar neuraxial procedures. Participation duration aligns with the surgical and post-operative periods ending in July 2027.

Lumoptik BRIGHTPOINT Reflectometer Device for Lumbar Epidural Placement