Transcutaneous Auricular Neurostimulation After Lumbar Fusion Surgery

Pain, Postoperative Clinical Trial

Official title:

Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients Undergoing Lumbar Fusion Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06100172
• Other study ID #: STU-2023-0197
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Alex Valadka, MD
• Phone: 214-645-2300
• Email: alex.valadka[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study, entitled "Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients Undergoing Lumbar Fusion Surgery", is to demonstrate whether transcutaneous auricular neurostimulation (tAN) can non-invasively reduce the perception of pain in patients undergoing lumbar fusion 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.

Description:

This study is designed as a randomized, double-blind, sham-controlled, single-center, clinical trial in which 20 patients undergoing lumbar fusion surgery will be randomized 1:1 into one of two treatment groups:

1. Group 1 (n=10): Active tAN + standard care

2. Group 2 (n=10): Sham tAN + standard care

Stimulation:

Participants undergoing lumbar fusion surgery will be randomized to receive either active or sham tAN treatment according to the following time points:

• Pre-operative: 30 minutes in the hour prior to surgery

• Intra-operative: 30 minutes before the end of surgery

• Post-operative: 30 minutes at 3 and 6 hours after surgery

• Inpatient: Four 30-minute sessions on Day 2

Blood Draws

Participants will have blood samples collected at the following time points:

• Day 1 (Day of Surgery)

• Day 2 (Day 1 post-surgical)

Follow up Visits Participants will have study follow up visits on Days 7 and Day 14. These visits can either be conducted either via a secure telehealth video visit, or in person visit.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Medically cleared to undergo a lumbar fusion surgery

2. 18-85 years of age

3. English Proficiency

4. Participants must be able to provide informed consent and function at an intellectual level sufficient for study requirements

Exclusion Criteria:

1. Current evidence of an uncontrolled and/or clinically significant medical condition

2. History of bleeding disorders or coagulopathy

3. History of seizures or epilepsy

4. History of neurological diseases or traumatic brain injury

5. Use of illegal recreational drugs

6. Presence of devices, e.g. pacemakers, cochlear prosthesis, neuro-stimulators

7. Use of acupuncture within 4 weeks of surgery

8. Grossly abnormal external ear anatomy or active ear infection

9. Women of childbearing potential, not using effective contraception per investigator judgment or not willing to comply with contraception for the duration of the study

10. Females who are pregnant or lactating

11. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

Related Conditions & MeSH terms

• Lumbar Spine Injury
• Opioid Use
• Pain, Postoperative
• Spinal Injuries

Intervention

Device:
• Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)
This 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
This device looks like the active device, but no stimulation will be delivered.

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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"	Baseline, 3 hours post-operation
Primary	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"	Baseline, 6 hours post-operation
Primary	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"	Baseline, day 2 post-operation
Primary	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"	Baseline, day 14 post-operation
Secondary	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.	3 hours post-surgery
Secondary	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.	6 hours post-surgery
Secondary	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.	Day 2 post-surgery
Secondary	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.	Day 7 post-surgery
Secondary	Mean total postoperative opioid consumption (morphine equivalent dose) at Day 14 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.	Day 14 post-surgery
Secondary	Mean percent change in C-reactive protein (CRP) levels from baseline at Day 1 (intra-op)	CRP blood samples collected will be used to measure the amount of inflammation in the body at the time points stated, and changes will be recorded and compared between the 2 groups. Plasma levels of C-reactive protein will be determined by the immunoprecipitation method using an in vitro diagnostic assay.	Baseline and at Day 1 (intra-op)
Secondary	Mean percent change in C-reactive protein (CRP) levels from baseline at 6 hours post-op	CRP blood samples collected will be used to measure the amount of inflammation in the body at the time points stated, and changes will be recorded and compared between the 2 groups. Plasma levels of C-reactive protein will be determined by the immunoprecipitation method using an in vitro diagnostic assay.	Baseline and at 6 hours post-op
Secondary	Mean percent change in C-reactive protein (CRP) levels from baseline at Day 2 post-op	CRP blood samples collected will be used to measure the amount of inflammation in the body at the time points stated, and changes will be recorded and compared between the 2 groups. Plasma levels of C-reactive protein will be determined by the immunoprecipitation method using an in vitro diagnostic assay.	Baseline and at Day 2 post-op
Secondary	Mean percent change in TNF-alpha levels from baseline at Day 1 (intra-op)	TNF-alpha blood samples collected will be used to measure the amount of inflammation in the body at the time points stated, and changes will be recorded and compared between the 2 groups.	Baseline and at Day 1 (intra-op)
Secondary	Mean percent change in TNF-alpha levels from baseline at 6 hours post-op	TNF-alpha blood samples collected will be used to measure the amount of inflammation in the body at the time points stated, and changes will be recorded and compared between the 2 groups.	Baseline and at 6 hours post-op
Secondary	Surgery time (incision to closure)	A comparison of the surgery times from incision to closure will be compared between the 2 groups to determine if the tAN affects the surgery time. The times will be recorded for each case, and then compared between the two groups. Surgery time - calculated as time from first incision to closure.	Day 1- during surgery [Surgery start (incision) to closure of surgical site]
Secondary	Estimated mean total blood loss	The volume of blood loss will be recorded for each case, and then the 2 groups will be compared. Comparision is based on end volume recorded at incision closure.	Day 1- During surgery [Surgery start (incision) to closure]