Clinical trial NCT06020508: Lumoptik BRIGHTPOINT Reflectometer Device for Lumbar Epidural Placement
Official title: Pilot Study for Human Clinical Trial to Evaluate the BRIGHTPOINT Reflectometer Device As Secondary Confirmation to Loss of Resistance in Lumbar Epidural Placement
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lumbar Spine Surgery
Keywords: epidural
neuraxial
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled to have surgery at the Hospital for Special Surgery that will require a lumbar neuraxial procedure requiring an epidural needle.

Brief 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.

Detailed description: There have been few improvements to the LOR technique from a device standpoint in recent years, and those that options do exist have not achieved widespread clinical use. The devices that do exist are variations on pressure sensors, some automate the "resistance" by placing various systems in place to apply a pressure to the plunger so that it will inject when the epidural space is accessed without the practitioner doing it themselves. This concept is represented by devices such as the Epimatic syringe from Vygon. Others improve on this concept by monitoring the pressure required to inject a set volume of fluid, thus being able to differentiate between true and false losses, as during false losses the pressure will increase as more fluid is injected. This system is represented by the CompuFlo Device by Milestone Scientific.

The BrightPoint Epidural device is the first system that utilizes multispectral reflectometry in order to identify the epidural space. This technology has the theoretical benefit over pressure-based systems of being able to identify and differentiate between different issue types (muscle, ligament, bone) as the needle is advanced towards the epidural space. Lumoptik, the company behind the BrightPoint Epidural device, is an early-stage startup based in Cleveland, Ohio. The main questions this trial 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?

This trial is being conducted to improve our current standard of care in neuraxial placement of loss-of-resistance. While the loss of resistance technique is tried and true, especially in experienced hands, complications such as dural punctures, misplaced epidurals, patchy epidurals, neurologic injuries, and intravascular catheters can occur even in experienced hands. All of which can cause significant patient morbidity and costs to the healthcare system, and as is shown in the Lacombe attached, the effects of dural puncture can be long lived for the patient. There can also be a steep learning curve when learning the technique, with the frequency of inadvertent dural punctures significantly higher in the early stages of learning the procedure. Therefore, we as a specialty are obligated to evaluate potential improvements to our current way of practice to reduce the burden to our patients from the complications of our interventions.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Real time confirmation of epidural space with loss of resistance technique
timeFrame: Post-operation (after the surgery is complete)
Secondary outcomes:
measure: Clinical (anesthesiologist) opinions on Lumoptik Bright Point Epidural device
timeFrame: Post-operation (after the surgery is complete)
measure: Color graphics aid in the identification of needle tips.
timeFrame: Post-operation (after the surgery is complete)
measure: The time it takes to insert the epidural needle into the patient's skin.
timeFrame: From "in OR time" to "time when needle is inserted"
measure: The time it takes to successfully identify the epidural space.
timeFrame: From "time when needle is inserted" to "time when epidural space is identified"
measure: The percentage of Successful Neuraxial Procedures
timeFrame: Post-operation (after the surgery is complete)
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Michael Singleton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lacombe A, Downey K, Ye XY, Carvalho JCA. Long-term complications of unintentional dural puncture during labor epidural analgesia: a case-control study. Reg Anesth Pain Med. 2022 Jun;47(6):364-369. doi: 10.1136/rapm-2021-103266. Epub 2022 Mar 25.
citation: van der Hek H, Plomp HN. Occupational stress management programmes: a practical overview of published effect studies. Occup Med (Lond). 1997 Apr;47(3):133-41. doi: 10.1093/occmed/47.3.133.