Clinical trial NCT06100172: Transcutaneous Auricular Neurostimulation After Lumbar Fusion Surgery
Official title: Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients Undergoing Lumbar Fusion Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Opioid Use
Lumbar Spine Injury
Keywords: Lumbar Fusion
Transcutaneous auricular neurostimulation (tAN)
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double blind, sham controlled.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 3 hours post-operation
timeFrame: Baseline, 3 hours post-operation
measure: Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 6 hours post-operation
timeFrame: Baseline, 6 hours post-operation
measure: Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at day 2 post-operation
timeFrame: Baseline, day 2 post-operation
measure: Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at day 14 post-operation
timeFrame: Baseline, day 14 post-operation
Secondary outcomes:
measure: Mean total postoperative opioid consumption (morphine equivalent dose) at 3 hours post-surgery
timeFrame: 3 hours post-surgery
measure: Mean total postoperative opioid consumption (morphine equivalent dose) at 6 hours post-surgery
timeFrame: 6 hours post-surgery
measure: Mean total postoperative opioid consumption (morphine equivalent dose) at Day 2 post-surgery
timeFrame: Day 2 post-surgery
measure: Mean total postoperative opioid consumption (morphine equivalent dose) at Day 7 post-surgery
timeFrame: Day 7 post-surgery
measure: Mean total postoperative opioid consumption (morphine equivalent dose) at Day 14 post-surgery
timeFrame: Day 14 post-surgery
measure: Mean percent change in C-reactive protein (CRP) levels from baseline at Day 1 (intra-op)
timeFrame: Baseline and at Day 1 (intra-op)
measure: Mean percent change in C-reactive protein (CRP) levels from baseline at 6 hours post-op
timeFrame: Baseline and at 6 hours post-op
measure: Mean percent change in C-reactive protein (CRP) levels from baseline at Day 2 post-op
timeFrame: Baseline and at Day 2 post-op
measure: Mean percent change in TNF-alpha levels from baseline at Day 1 (intra-op)
timeFrame: Baseline and at Day 1 (intra-op)
measure: Mean percent change in TNF-alpha levels from baseline at 6 hours post-op
timeFrame: Baseline and at 6 hours post-op
measure: Surgery time (incision to closure)
timeFrame: Day 1- during surgery [Surgery start (incision) to closure of surgical site]
measure: Estimated mean total blood loss
timeFrame: Day 1- During surgery [Surgery start (incision) to closure]
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Alex Valadka, MD
role: PRINCIPAL_INVESTIGATOR
References: