Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients Undergoing Lumbar Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain, Postoperative
- Sponsor
- University of Texas Southwestern Medical Center
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at day 2 post-operation
- Status
- Recruiting
- Last Updated
- 4 months ago
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: 1. Group 1 (n=10): Active tAN + standard care 2. 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 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.
Investigators
Alex Valadka
Professor
University of Texas Southwestern Medical Center
Eligibility Criteria
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
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 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])