Modulation of Post-operative Opioid Consumption and Pain by Intraoperative Methadone for Cancer Related Spinal Surgery - An Investigator Initiated Trial (IIT), Cluster Randomization Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- opioid requirement in morphine equivalent
研究概览
简要总结
The researchers are doing this study to find out whether giving methadone during spinal surgery helps manage pain in the first 72 hours after surgery better than other standard pain medications. Participants' pain will be measured by how much pain is reported after surgery, and how much additional pain medication is needed to lower pain levels. The researchers will look at whether giving methadone during surgery reduces the need for other pain medications after surgery. In addition, the team will compare the effects of the two standard treatments- one with methadone and one without methadone to to evaluate which one works best.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (between 18-75 years of age) scheduled for extradural spine surgery with instrumentation (greater than or equal to two levels and including minimally invasive) of expected duration ≥ 2 hours
- •Postoperative hospital stay expected to be ≥ 2 nights at the time of consent
排除标准
- •Use of methadone currently or within the previous 6 weeks
- •Drug misuse history (e.g., ketamine, cocaine, heroin, amphetamine, methamphetamine, MDMA, phencyclidine, lysergic acid, mescaline, psilocybin).
- •Current use of opioid antagonist/partial antagonist (i.e. buprenorphine).
- •Current or past diagnosis of a Major Psychiatric disorder (such as Schizophrenia, dementia, delirium).
- •Patients with a BMI ≥ 36 kg/m2
- •2nd or 3rd degree heart block as assessed by preoperative EKG.
- •QTc > 450 msec on preoperative EKG.
- •Documentation of congestive heart failure and/or ejection fraction < 30% if recorded in the Pre-Operative Record.
- •Contraindication to use of any analgesic medications listed in the ERAS pathways (acetaminophen, gabapentin, celecoxib, IV opioids).
- •Any known hypersensitivity to methadone.
- •Pregnant or breastfeeding.
- •Abnormal liver function tests as related to the MSK guidelines for use of IV acetaminophen: ALT greater than 2 x Upper Limit of Normal (> 75 U/L)
- •Serum Creatinine > 1.5 mg/dl
- •Instrumented spine cases of less than 2 levels
- •All non-instrumented spine cases
- •All intradural tumor resections
- •All "take backs" that occur within 72 hours of surgery (wound revisions, hematomas, etc.)
研究组 & 干预措施
Methadone bolus during surgery
Patients will be administered methadone 0.2 mg/kg (max 20 mg).
干预措施: Methadone (Drug)
No Methadone during surgery
No Methadone during surgery
结局指标
主要结局
opioid requirement in morphine equivalent
时间窗: within 72 hours post-surgery
To see if giving methadone during surgery reduces the need for other pain medications after surgery
次要结局
未报告次要终点