Transcutaneous Auricular Neurostimulation After Lumbar Fusion Surgery
- Conditions
- Opioid UseLumbar Spine InjuryPain, Postoperative
- Interventions
- Device: Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)Device: Sham Control Device
- Registration Number
- NCT06100172
- Lead Sponsor
- University of Texas Southwestern Medical Center
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Medically cleared to undergo a lumbar fusion surgery
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active tAN + standard of care (SOC) for post-operative pain management for lumbar fusion patients. Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) 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 Sham tAN + standard of care (SOC) for post-operative pain management for lumbar fusion patients. Sham Control Device 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
- Primary Outcome Measures
Name Time Method 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 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 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 Outcome Measures
Name Time Method 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.
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.
Estimated mean total blood loss Day 1- During surgery [Surgery start (incision) to closure] 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.
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 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 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 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 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 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.
Trial Locations
- Locations (1)
UT Southwestern Medical Center
šŗšøDallas, Texas, United States