Evaluation of Objective Pain Measurement Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Average Self-report Pain Score
研究概览
简要总结
This study will attempt to objectively measure pain with an experimental device. The investigators will apply the device to measure patients "pain" due to uterine contractions during routine clinical care to correlate patients verbal pain ratings and analgesia requirements to that measured by the device. A brain oxygenation device, Edwards Foresight, will be used to concurrently to monitor brain oxygenation and hemodynamics, so the relationship between the CereVu ROPA device objective measure of pain and brain oxygenation/hemodynamic changes and patient-reported pain can be determined.
详细描述
Despite all the progress in our understanding of the basic mechanisms of pain, the gold standard for measuring pain is still a subjective verbal numeric rating scale rating (0-10) obtained from the individual reporting pain. This method is not objective and cannot be used in all patient populations. This study will attempt to objectively measure pain in laboring mothers with a pain measurement device. The investigators aim to 1) see if the pain measurement device (CereVu ROPA) is capable of reflecting different levels of pain ratings in patients in labor having uterine contractions and then changes in pain after receiving different neuraxial techniques for labor pain and to 2) additionally determine the relationship between the CereVu ROPA device, brain oxygenation/hemodynamic changes and patient-reported pain scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-50
- •ASA 1 or 3 +/-E
- •Patient requesting epidural labor analgesia
- •Good toco tracing (clearly showing contractions at least every 5 minutes)
- •Pain score greater than or equal to 3 out of 10 with contractions
排除标准
- •History of chronic pain
- •History of chronic opioid use
- •BMI > 45
- •Allergy to sensor adhesive material, local anesthetic or opioids
- •Contraindication to neuraxial block
- •Patient on magnesium infusion
- •Inability to give informed consent or understand English
结局指标
主要结局
Average Self-report Pain Score
时间窗: During labor up to 2 hours after epidural
Average patient self-reported pain score on 0 to 10 scale (higher scores correspond to more pain)
Correlation of Average Device Pain Score to Average Self-report Pain Score
时间窗: During labor up to 2 hours after epidural
Pearson correlation
Correlation Between Pain Score and Brain Oxygenation
时间窗: During labor up to 2 hours after epidural
Pearson correlation between patient self-reported pain score on 0 to 10 scale (higher scores correspond to more pain) and brain oxygenation (0-100%). This outcome will be assessed in part 2 only.
Correlation Between Pain Score and Noninvasive Blood Pressure
时间窗: During labor up to 2 hours after epidural
Pearson correlation between patient self-reported pain score on 0 to 10 scale (higher scores correspond to more pain) and hemodynamic parameter noninvasive blood pressure. This outcome will be assessed in part 2 only.
Correlation Between Pain Score and Heart Rate
时间窗: During labor up to 2 hours after epidural
Pearson correlation between patient self-reported pain score on 0 to 10 scale (higher scores correspond to more pain) and hemodynamic parameter heart rate. This outcome will be assessed in part 2 only.
Correlation Between Pain Score and Pulse Oximetry
时间窗: During labor up to 2 hours after epidural
Correlation between patient self-reported pain score on 0 to 10 scale (higher scores correspond to more pain) and hemodynamic parameter pulse oximetry (Sp02). This outcome will be assessed in part 2 only.
次要结局
- Time to Reach Pain Score 2 or Less Out of 10(within 45 minutes after the block placement)
- Time Taken for Pain Device Score to be Below Validated Value(within 45 minutes after the block placement)
- Patient Reported Pain Scores After Block(Up to approximately 45 minutes after the block placement)
- Device Recorded Pain Scores After Block(Up to approximately 45 minutes after the block placement)
- Dermatomal Level at 45 Minutes After Block Placement as a Measure of Sensory Blockade Level(45 minutes)
- Count of Participants With Block Failures(within 45 minutes after the block placement)
- Count of Participants With Maternal Side Effects(within 45 minutes after the block placement)
- Count of Participants With Fetal Side Effects(within 45 minutes after the block placement)
- Count of Participants Needing Physician Intervention(within 45 minutes after the block placement)
- Time From Epidural to Delivery(from epidural to delivery (average approximately 9 hours))
- Count of Participants With Normal Vaginal Delivery(from epidural to delivery (expected average: 24 hours))
- Count of Participants With Assisted Vaginal Delivery(from epidural to delivery (expected average: 24 hours))
- Count of Participants With Cesarean Delivery(from epidural to delivery (expected average: 24 hours))
研究者
Brendan Carvalho
Chief, Division of Obstetric Anesthesia Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine
Stanford University