Lumbar Spine Injury, Opioid Use, Pain, Postoperative
Conditions
Keywords
Lumbar Surgery, Transcutaneous auricular neurostimulation (tAN)
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.
Interventions
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.
DEVICESham Control Device
This device looks like the active device, but no stimulation will be delivered.
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.
Intervention model description
Randomized, double blind, sham controlled.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Medically cleared to undergo a lumbar spine surgery, either spinal fusion with or without multilevel laminectomies, or lumbar multilevel laminectomies alone. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 3 hours post-operation | 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 | 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 2 post-operation | 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 day 14 post-operation | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean total postoperative opioid consumption (morphine equivalent dose) at Day 14 post-surgery | 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. |
| Mean percent change in C-reactive protein (CRP) levels from baseline at Day 1 (intra-op) | Baseline and 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. |
| Mean percent change in C-reactive protein (CRP) levels from baseline at 6 hours post-op | Baseline and 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. |
| Mean percent change in C-reactive protein (CRP) levels from baseline at Day 2 post-op | Baseline and 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. |
| Mean total postoperative opioid consumption (morphine equivalent dose) at 3 hours post-surgery | 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. |
| Mean percent change in TNF-alpha levels from baseline at 6 hours post-op | Baseline and 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. |
| Surgery time (incision to closure) | Day 1- during surgery [Surgery start (incision) to closure of surgical site] | 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. |
| Estimated mean total blood loss | Day 1- During surgery [Surgery start (incision) to closure] | During surgery, blood will be collected using cell saver technology which allows for accurate recording of total blood loss. The volume of blood loss will be recorded for each case, and then the 2 groups will be compared. Comparison is based on end volume recorded at incision closure. |
| Mean percent change in Tumor Necrosis factor (TNF)-alpha levels from baseline at Day 1 (intra-op) | Baseline and 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. |
| Mean total postoperative opioid consumption (morphine equivalent dose) at 6 hours post-surgery | 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. |
| Mean total postoperative opioid consumption (morphine equivalent dose) at Day 2 post-surgery | 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. |
| Mean total postoperative opioid consumption (morphine equivalent dose) at Day 7 post-surgery | 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. |
Countries
United States
Contacts
Primary ContactAlex Valadka, MD
Backup ContactTyfe Oderinde, MS
Outcome results
None listed