Transcutaneous Auricular Neurostimulation After Lumbar Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Texas Southwestern Medical Center
About this trial
The purpose of this study, entitled "Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients Undergoing Lumbar Surgery", is to demonstrate whether transcutaneous auricular neurostimulation (tAN) can non-invasively reduce the perception of pain in patients undergoing lumbar surgery. tAN is placed on and around the ear to non-invasively stimulate branches of the vagus and trigeminal nerves and modulate specific brain regions associated with pain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Medically cleared to undergo a lumbar spine surgery, either spinal fusion with or without multilevel laminectomies, or lumbar multilevel laminectomies alone.
18-85 years of age
English Proficiency
Participants must be able to provide informed consent and function at an intellectual level sufficient for study requirements
Disqualifiers
Current evidence of an uncontrolled and/or clinically significant medical condition
History of bleeding disorders or coagulopathy
History of seizures or epilepsy
History of neurological diseases or traumatic brain injury
Trial design
Design model
Parallel
Treatments tested in this trial
Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)
DeviceThis method of simultaneous vagal and trigeminal stimulation via the external ear is known as transcutaneous auricular neurostimulation (tAN), as the targets of electrical stimulation include the auricular branch of the vagus nerve (ABVN) and auriculotemporal nerve (ATN), which is a branch of the mandibular division of the trigeminal nerve. Electrodes applied to select dermatome regions can target ear neural structures and deliver non-invasive vagus nerve stimulation (VNS) and trigeminal nerve stimulation (TNS). Use of tAN for pain relief is an attractive alternative to pharmacologic and opioid-based approaches because it is safe and effective and presents no addiction liability.
Sham Control Device
DeviceThis device looks like the active device, but no stimulation will be delivered.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Active tAN + standard of care (SOC) for post-operative pain management for lumbar spine patients.Active comparator 1 intervention
Group B: Sham tAN + standard of care (SOC) for post-operative pain management for lumbar spine patients.Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 3 hours post-operation
Patients will be asked to report their level of pain using the Visual Analog Scale. Possible scores for VAS pain scale ranges from 0-10 where 0="no pain" to 10="severe pain"
Time frame
Baseline, 3 hours post-operation2
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 6 hours post-operation
Patients will be asked to report their level of pain using the Visual Analog Scale. Possible scores for VAS pain scale ranges from 0-10 where 0="no pain" to 10="severe pain"
Time frame
Baseline, 6 hours post-operation3
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at day 2 post-operation
Patients will be asked to report their level of pain using the Visual Analog Scale. Possible scores for VAS pain scale ranges from 0-10 where 0="no pain" to 10="severe pain"
Time frame
Baseline, day 2 post-operation4
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at day 14 post-operation
Patients will be asked to report their level of pain using the Visual Analog Scale. Possible scores for VAS pain scale ranges from 0-10 where 0="no pain" to 10="severe pain"
Time frame
Baseline, day 14 post-operationSecondary outcomes
1
Mean total postoperative opioid consumption (morphine equivalent dose) at 3 hours post-surgery
During the in-patient hospital stay, the dose and frequency of post -operative opioid use will recorded for both the placebo and active groups. The opioid usage between the 2 groups will be compared to determine if the active group required less opioid medications for pain reduction.
Time frame
3 hours post-surgery2
Mean total postoperative opioid consumption (morphine equivalent dose) at 6 hours post-surgery
During the in-patient hospital stay, the dose and frequency of post -operative opioid use will recorded for both the placebo and active groups. The opioid usage between the 2 groups will be compared to determine if the active group required less opioid medications for pain reduction.
Time frame
6 hours post-surgery3
Mean total postoperative opioid consumption (morphine equivalent dose) at Day 2 post-surgery
During the in-patient hospital stay, the dose and frequency of post -operative opioid use will recorded for both the placebo and active groups. The opioid usage between the 2 groups will be compared to determine if the active group required less opioid medications for pain reduction.
Time frame
Day 2 post-surgery4
Mean total postoperative opioid consumption (morphine equivalent dose) at Day 7 post-surgery
During the in-patient hospital stay, the dose and frequency of post -operative opioid use will recorded for both the placebo and active groups. The opioid usage between the 2 groups will be compared to determine if the active group required less opioid medications for pain reduction.
Time frame
Day 7 post-surgerySponsors and contacts
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Source ClinicalTrials.gov