The MDK Study: Using a Combination of Methadone-dexmedetomidine-ketamine for Postoperative Pain Control in Patients Undergoing Complex Spine Surgeries.
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- Effect of the MDK combination during surgery on postoperative opioid consumption
研究概览
简要总结
This study will investigate whether a combination of three anesthetic medications will reduce intraoperative and postoperative pain in patients undergoing complex spine surgery, and whether it will reduce the use of opioid pain medication after surgery.
详细描述
Dexmedetomidine, methadone and ketamine offer benefits when used as adjuncts in complex spine surgeries. Dexmedetomidine is reported to attenuate intraoperative stress responses without interfering with neuromonitoring while potentially improving postoperative pain control and reducing opioid consumption in complex spine surgery. Methadone use intraoperatively improves postoperative pain control and reduced opioid requirements following complex spine surgery. Consensus guidelines from the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists support the use of ketamine in acute pain management in surgeries like spine surgery. Perioperative ketamine use in spine surgery results in lower pain scores and reduced opioid utilization postoperatively. The use of dexmedetomidine, methadone and ketamine as adjuncts may improve postoperative pain control while reducing opioid requirements, lowering stress responses, and without significantly impacting neuromonitoring in complex spine surgery or increasing drug related adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-79 years of age
- •Patients undergoing complex spine surgery, defined as 3 or more levels
- •English-speaking
- •Able to consent for themselves
排除标准
- •Patients who are unable to consent to study participation in English
- •Patients who are unable to consent for themselves.
- •Patients with prolonged QT syndrome
- •Pregnancy
- •Additional screening measures:
- •Preoperative ECG will be performed in preoperative holding as part of standard of care to assess for prolonged QTc prior to administration of methadone as part of SOC.
- •Pregnancy test will be performed as part of SOC on the day of surgery.
研究组 & 干预措施
Intervention
Group receiving the methadone-dexmedetomidine-ketamine medication combination intravenously during anesthesia for complex spine surgery.
干预措施: Methadone-dexmedetomidine-ketamine combination (Drug)
Routine
Group that receives routine anesthesia with opioid medications during complex spine surgery.
结局指标
主要结局
Effect of the MDK combination during surgery on postoperative opioid consumption
时间窗: 72 hours postoperatively
Determine if use of dexmedetomidine, methadone, and ketamine given together intraoperatively has an effect on postoperative opioid consumption following complex spine surgery of 3 or more levels
次要结局
- Effect of MDK combination on overall postoperative pain scores.(72 hours after surgery)
- Incidence of opioid-related adverse events(72 hours postoperatively)
研究者
Antoinette Burger
Assistant Professor
University of Missouri-Columbia