Percutaneous Auricular Neuromodulation for Postoperative Analgesia: A Randomized, Participant- and Observer-Masked, Sham-Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- AVERAGE Pain Measured With the Numeric Rating Scale First 5 Postoperative Days
研究概览
简要总结
The moderate-to-severe pain many patients experience following surgery is often treated with opioids, which are associated with side effects such as nausea/vomiting, sedation, and respiratory depression (and a risk of abuse, dependence, and diversion). Potent site-specific analgesia with fewer side effects may be provided with peripheral nerve blocks. However, these too have limitations such as a duration of action measured in hours, while the pain from surgery is usually measured in days or weeks. Peripheral nerve stimulation or "neuromodulation" is an alternative method of pain control involving the introduction of electrical current to stimulate various nerves that do not carry pain sensations, but which then decreases communication between pain fibers and the spinal cord and/or brain. Placing small electrodes specifically in the area of the ear is called "auricular neuromodulation" and is theorized to function by stimulating various cranial and peripheral nerves that influence a part of the brain called the "limbic system" which is involved with many aspects of behavior including responses to stress. A device that delivers auricular neuromodulation, the "Bridge" system, is approved by the United States Food and Drug Administration for use to reduce symptoms associated with opioid withdrawal for up to 5 days. However, one prospective and two published retrospective studies suggest that it may provide postoperative analgesia as well. The device itself is relatively simple to apply; has few contraindications, side effects, or adverse events; and has no potential for dependence, abuse, or diversion. Therefore, it has the potential to concurrently improve analgesia and decrease or even negate opioid requirements following surgery, only without the limitations of opioids and peripheral nerve blocks. The purpose of this pilot study is to explore the possibility of treating postoperative pain with percutaneous auricular neuromodulation, optimize the study protocol, and estimate the treatment effect in preparation for developing a subsequent definitive clinical trial.
详细描述
The proposed study will be a randomized, participant- and observer-masked, sham-controlled, parallel-arm, human participants pilot study with two primary aims:
Specific Aim 1: To determine the feasibility and optimize the protocol for a subsequent clinical trial that will compare the addition of percutaneous auricular neuromodulation to usual and customary analgesia following moderate-to-severely painful surgical procedures.
Specific Aim 2: To estimate the treatment effect of adding percutaneous auricular neuromodulation to usual and customary analgesia on pain and opioid consumption following various surgical procedures. This will provide an idea of the optimal surgical procedures amenable to this analgesic technique and allow determination of the required sample size of a subsequent definitive clinical trial.
Hypothesis 1: Auricular neuromodulation decreases pain in the 5 days following moderate-to-severely painful surgical procedures currently treated with a single-injection peripheral nerve block.
Hypothesis 2: Auricular neuromodulation decreases opioid use in the 5 days following moderate-to-severely painful surgical procedures currently treated with a single-injection peripheral nerve block.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The Investigational Drug Service will create the randomization tables and provide the investigators with the appropriate device (active or sham), leaving all participants, investigators, and the statistician masked to treatment group assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing one of these surgical procedures as a primary procedure (not revision):
- •septoplasty [infraorbital nerve block]
- •laparoscopic cholecystectomy [transversus abdominis nerve block]
- •laparoscopic sleeve gastrectomy [transversus abdominis nerve block]
- •non-mastectomy breast surgery [paravertebral nerve block]
- •percutaneous nephrolithotomy [erector spinae plane nerve block]
- •inguinal hernia repair [transversus abdominis nerve block]
- •knee arthroplasty [adductor canal nerve block]
- •hip arthroplasty [pericapsular nerve group block]
- •shoulder acromioclavicular joint repair, labral repair, subacromial decompression, or Bankart repair (without rotator cuff repair) [interscalene nerve block]
- •orthopedic hardware removal anticipated to be at least moderately painful postoperatively [various peripheral nerve blocks]
- •analgesic plan includes a single-injection peripheral nerve block with a long-acting local anesthetic [may be waived for hip arthroplasty]
- •age 18 years or older.
排除标准
- •concurrent use of another electric stimulator (e.g., cardiac pacemaker)
- •bleeding disorder
- •anticoagulation
- •skin abnormality at the treatment site
- •psoriasis vulgaris
- •morbid obesity as defined by a body mass index > 40
- •history of opioid abuse
- •inability to communicate with the investigators or hospital staff
- •bilateral or multi-stage surgical procedures
- •incarceration
- •chronic opioid or tramadol use (daily use within the 2 weeks prior to surgery and duration of use > 4 weeks)
- •neuro-muscular deficit of the surgical area/limb.
结局指标
主要结局
AVERAGE Pain Measured With the Numeric Rating Scale First 5 Postoperative Days
时间窗: The first 5 postoperative days
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. The outcome will the mean value of daily average pain scores measured with the Numeric Rating Scale. The primary outcome measure will be the mean value of the average daily pain measured on postoperative days 1-5.
Total OPIOID Consumption From Recovery Room Discharge Until the Data Collection Phone Call on Postoperative Day 5 (Measured in Oral Oxycodone Equivalents)
时间窗: Postoperative days 0-5
Total opioid consumption from recovery room discharge until the data collection phone call on postoperative day 5 (measured in oral oxycodone equivalents).
次要结局
- AVERAGE Pain Measured With the Numeric Rating Scale(Recorded on postoperative days 1-8 for the previous 24-hour period)
- CURRENT Pain at the Time of the Data-collection Phone Call Measured With the Numeric Rating Scale(Recorded on postoperative days 2, 4, 6, and 8)
- WORST (Highest or Maximum) Pain Measured With the Numeric Rating Scale(Recorded on postoperative days 1-8 for the previous 24-hour period)
- LEAST (Lowest or Minimum) Pain Measured With the Numeric Rating Scale(Recorded on postoperative days 2, 4, 6, and 8 for the previous 24-hour period)
- Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)(Recorded on postoperative days 1-8)
- Brief Pain Inventory, Short Form (Interference Subscale)(Recorded on postoperative days 2, 4, 6, and 8 for the previous 24-hour period)
- Awakenings Due to Pain(Recorded on postoperative days 1-8 for the previous night)
- Masking(Recorded on postoperative day 1)
- Hospitalization Duration Measured in Days(Up to 2 weeks after surgery)
- Tourniquet Duration(Intraoperative (within the operating room))
- Surgical Duration(Intraoperative (within the operating room))
研究者
Brian M. Ilfeld, MD, MS
Professor of Anesthesiology, In Residence
University of California, San Diego