RecruitingNCT06020508

Lumoptik BRIGHTPOINT Reflectometer Device for Lumbar Epidural Placement

Pilot Study for Human Clinical Trial to Evaluate the BRIGHTPOINT Reflectometer Device as Secondary Confirmation to Loss of Resistance in Lumbar Epidural Placement

Sponsor

Hospital for Special Surgery, New York

Enrollment

36 participants

Start Date

Sep 12, 2023

Study Type

OBSERVATIONAL

Conditions

Lumbar Spine Surgery

Summary

The goal of this clinical trial is to test the BrightPoint Epidural device as the first system to use multispectral reflectometry to find the epidural space in lumbar neuraxial procedures requiring epidural needle. The main questions it aims to answer are: 1. Is the device a qualitatively effective secondary confirmation of Loss of Resistance? 2. Is the device a qualitatively effective training tool for educating trainees in how to perform lumbar epidurals? Participants will undergo a neuraxial procedure in which the attending anesthesiologist will use the BrightPoint epidural device to form an opinion on its effectiveness in confirming epidural space access.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria2

Any patient undergoing a lumbar neuraxial procedure requiring epidural needle
Age 18-99

Exclusion Criteria5

Previous lumbar spine surgery
Any known spinal abnormality that would interfere with successfully advancing a needle into the epidural space
Any patient requiring epidural needle longer than 4 inches
Any contraindication to neuraxial anesthesia
Tattoo at the site of epidural insertion

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Interventions

DEVICEGroup 1 - Lumoptik BrightPoint Epidural Device

Participants will undergo a neuraxial procedure to measure loss of resistance with saline in conjunction with the Lumoptik BrightPoint Epidural Device.