Randomized Prospective Study Comparing Intrathecal Morphine vs Intravenous Methadone for Postoperative Analgesia Following Retroperitoneal Lymph Node Dissection (RPLND)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- IV morphine equivalent (MME)
研究概览
简要总结
This randomization study is to compare both intrathecal morphine and intravenous methadone, which are both standard of care, for pain management in patients undergoing retroperitoneal lymph node dissections for primary testicular cancer. Investigators plan to compare their analgesic effectiveness at different postoperative time intervals.
详细描述
In this study, investigators aim to compare intravenous methadone combined with standard multimodal analgesia and surgical infiltration of local anesthesia to intrathecal duramorph with standard multimodal analgesia and surgical infiltration of local anesthesia. In this single blinded prospective randomized control trial, investigators hypothesize that intravenous methadone will provide a significant reduction in patient opioid consumption when compared to intrathecal opioid analgesia in the first 24 hours in patients who undergo PC/RPLND.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
盲法说明
The primary investigator or his/her designee will inform the anesthesiology team caring for each subject of the arm of the study they are in for each case. Subjects and research staff doing post-operative assessments will be blinded to the randomization.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing a virgin (chemotherapy has not been used) or post- chemotherapy retroperitoneal lymph node dissection for primary testicular cancer at IU Health AAHC
- •ASA Class 1, 2, 3
- •Age 18 to 80 years; Male
- •BMI less than 50kg/m2
排除标准
- •Any contraindication for neuraxial analgesia
- •Patient on home methadone at any dose
- •Any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
- •Known true allergy to the study medications (morphine, bupivacaine, acetaminophen, methadone)
- •Any history of substance abuse in the past 6 months which would include heroin or any other illegal street drugs
- •End stage liver disease, end stage renal disease
- •Patient staying intubated after surgery
- •Patient (home dose) taking more than 30mg PO morphine equivalent (PME) per day
- •Any additional surgical procedures to the patient with a different surgical incision compared to the standard laparotomy for the RPLND procedure, i.e. thoracic tumor reduction
研究组 & 干预措施
Intrathecal Morphine
Intrathecal preservative free morphine (duramorph) 200 mcg with 7.5mg of hyperbaric bupivacaine placed by a spinal needle prior to induction of general anesthesia (n=71)
干预措施: Inrathecal Morphine (Drug)
Intravenous Methadone
Intravenous methadone dosed at 0.2 mg/kg Ideal Body weight up to a maximum dose of 20mg, rounded to the nearest milligram, for all patients given during the induction of general anesthesia (n=71)
干预措施: Intravenous Methadone (Drug)
结局指标
主要结局
IV morphine equivalent (MME)
时间窗: First 24 hours postoperative
Cumulative Milligrams of morphine equivalent (MME) consumption
次要结局
- Opioid consumption(24 hours after arrival time to post anesthesia care unit)
- Opioid side effect-Nausea(after arrival time to post anesthesia care unit until 24 hours/completion of study)
- Opioid side effects-Vomiting(after arrival time to post anesthesia care unit until 24 hours/completion of study)
- Opioid side effects-Pruritis(after arrival time to post anesthesia care unit until 24 hours/completion of study)
- Adverse Events(after arrival time to post anesthesia care unit until 24 hours/completion of study)
- Opioid side effects-Respiratory Depression(after arrival time to post anesthesia care unit until 24 hours/completion of study)
- Pain Scores(12 hours after arrival time to post anesthesia care unit)
- Opioid consumption(1 hour after arrival time to post anesthesia care unit)
- Opioid consumption(12 hours after arrival time to post anesthesia care unit)
- Pain Scores(24 hours after arrival time to post anesthesia care unit)
研究者
Kevin Michael Backfish-White, MD
Dept. of Anesthesiology, Asst. Professor
Indiana University