Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients Undergoing Lumbar Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at day 2 post-operation
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at day 2 post-operation
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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"
次要结局
- 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])
研究者
Alex Valadka
Professor
University of Texas Southwestern Medical Center