Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients Undergoing Lumbar Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at day 2 post-operation
Study Overview
Brief Summary
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.
Detailed Description
This study is designed as a randomized, double-blind, sham-controlled, single-center, clinical trial in which 20 patients undergoing lumbar spine surgery will be randomized 1:1 into one of two treatment groups:
- Group 1 (n=10): Active tAN + standard care
- Group 2 (n=10): Sham tAN + standard care
Stimulation:
Participants undergoing lumbar 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
On the day of surgery, subjects will be randomized 1:1 to either the active stimulation group or the sham group. In the sham group, the device looks like the active device, but it will not deliver any electrical stimulation to the vagus or trigeminal nerves.
Both groups will receive the SOC for post-operative pain management for lumbar surgery patients.
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •Use of illegal recreational drugs
- •Presence of devices, e.g. pacemakers, cochlear prosthesis, neuro-stimulators
- •Use of acupuncture within 4 weeks of surgery
- •Grossly abnormal external ear anatomy or active ear infection
- •Women of childbearing potential, not using effective contraception per investigator judgment or not willing to comply with contraception for the duration of the study
- •Females who are pregnant or lactating
- •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
Arms & Interventions
Active tAN + standard of care (SOC) for post-operative pain management for lumbar spine patients.
Subjects will be randomized to receive the active device on the day of surgery.
Subjects will receive 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
Intervention: Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) (Device)
Sham tAN + standard of care (SOC) for post-operative pain management for lumbar spine patients.
Subjects will be randomized to receive the sham device on the day of surgery.
Subjects will receive 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
Intervention: Sham Control Device (Device)
Outcomes
Primary Outcomes
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at day 2 post-operation
Time Frame: Baseline, 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"
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 3 hours post-operation
Time Frame: Baseline, 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"
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 6 hours post-operation
Time Frame: Baseline, 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"
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at day 14 post-operation
Time Frame: Baseline, 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"
Secondary Outcomes
- Mean total postoperative opioid consumption (morphine equivalent dose) at 3 hours post-surgery(3 hours post-surgery)
- Mean total postoperative opioid consumption (morphine equivalent dose) at 6 hours post-surgery(6 hours post-surgery)
- Mean total postoperative opioid consumption (morphine equivalent dose) at Day 2 post-surgery(Day 2 post-surgery)
- Mean total postoperative opioid consumption (morphine equivalent dose) at Day 7 post-surgery(Day 7 post-surgery)
- Mean total postoperative opioid consumption (morphine equivalent dose) at Day 14 post-surgery(Day 14 post-surgery)
- Mean percent change in C-reactive protein (CRP) levels from baseline at Day 1 (intra-op)(Baseline and at Day 1 (intra-op))
- Mean percent change in C-reactive protein (CRP) levels from baseline at 6 hours post-op(Baseline and at 6 hours post-op)
- Mean percent change in C-reactive protein (CRP) levels from baseline at Day 2 post-op(Baseline and at Day 2 post-op)
- Mean percent change in TNF-alpha levels from baseline at 6 hours post-op(Baseline and at 6 hours post-op)
- Surgery time (incision to closure)(Day 1- during surgery [Surgery start (incision) to closure of surgical site])
- Estimated mean total blood loss(Day 1- During surgery [Surgery start (incision) to closure])
- Mean total postoperative opioid consumption (morphine equivalent dose) at Day 7 post-surgery(Day 7 post-surgery)
- Mean total postoperative opioid consumption (morphine equivalent dose) at 3 hours post-surgery(3 hours post-surgery)
- Mean total postoperative opioid consumption (morphine equivalent dose) at 6 hours post-surgery(6 hours post-surgery)
- Mean total postoperative opioid consumption (morphine equivalent dose) at Day 2 post-surgery(Day 2 post-surgery)
- Mean total postoperative opioid consumption (morphine equivalent dose) at Day 14 post-surgery(Day 14 post-surgery)
- Mean percent change in C-reactive protein (CRP) levels from baseline at Day 1 (intra-op)(Baseline and at Day 1 (intra-op))
- Mean percent change in C-reactive protein (CRP) levels from baseline at 6 hours post-op(Baseline and at 6 hours post-op)
- Mean percent change in C-reactive protein (CRP) levels from baseline at Day 2 post-op(Baseline and at Day 2 post-op)
- Mean percent change in Tumor Necrosis factor (TNF)-alpha levels from baseline at Day 1 (intra-op)(Baseline and at Day 1 (intra-op))
- Mean percent change in TNF-alpha levels from baseline at 6 hours post-op(Baseline and at 6 hours post-op)
- Surgery time (incision to closure)(Day 1- during surgery [Surgery start (incision) to closure of surgical site])
- Estimated mean total blood loss(Day 1- During surgery [Surgery start (incision) to closure])
Investigators
Alex Valadka
Professor
University of Texas Southwestern Medical Center