Methadone Versus Intrathecal Hydromorphone for Postoperative Analgesia in Patients Undergoing Surgery for Gynecologic Malignancy Via Midline Laparotomy Receiving Liposomal Bupivacaine
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Difference in pain scores
研究概览
简要总结
This phase IV trial compares methadone versus hydromorphone given in the fluid-filled space between the thin layers of tissue that cover the brain and spinal cord (intrathecal) for postoperative pain relief in patients with gynecologic cancer undergo surgery. Methadone binds to opioid receptors in the central nervous system and is a long-acting opioid pain medication. Intrathecal hydromorphone works by changing the way the brain and nervous system respond to pain and is similar to an epidural. This trial may help researchers determine if methadone works as well as intrathecal hydromorphone for pain relief after surgery in patients with gynecologic cancer.
详细描述
PRIMARY OBJECTIVE:
I. To determine whether intravenous methadone can provide comparable analgesia to an intrathecal injection of hydromorphone.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive methadone intravenously (IV) during induction of general anesthesia for standard of care (SOC) surgery.
ARM II: Patients receive hydromorphone intrathecally (IT) prior to induction of general anesthesia for SOC surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Undergoing surgery with a laparotomy for gynecologic malignancy
- •Planned inpatient admission greater than 24 hours
排除标准
- •Chronic pain requiring greater than 20 morphine milligram equivalents of opioid medications as an outpatient
- •Prolonged corrected QT interval (QTc) > 500ms
- •Chronic kidney disease with estimated glomerular filtration rate (eGFR) < 30 milliliters per minute (mL/min)
- •Documented cirrhosis
- •Preoperative platelets (PLT) < 100
- •Preoperative international normalized ratio (INR) > 1.1
- •Inappropriate cessation of anticoagulation medications prior to surgery
- •Intolerance to hydromorphone or methadone
- •Contraindication to administration of liposomal bupivacaine
- •Subsequent surgeries after index surgery
研究组 & 干预措施
Arm I (methadone)
Patients receive methadone IV during induction of general anesthesia for SOC surgery.
干预措施: Methadone (Drug)
Arm I (methadone)
Patients receive methadone IV during induction of general anesthesia for SOC surgery.
干预措施: Questionnaire Administration (Other)
Arm II (hydromorphone)
Patients receive hydromorphone IT prior to induction of general anesthesia for SOC surgery.
干预措施: Hydromorphone (Drug)
Arm II (hydromorphone)
Patients receive hydromorphone IT prior to induction of general anesthesia for SOC surgery.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Difference in pain scores
时间窗: Baseline, upon leaving post-anesthesia care unit (PACU), and at 4, 8, and 12 hours, up to 24 hours postoperatively
Will be assessed per group \[intravenous (IV) methadone or intrathecal (IT) hydromorphone\] by patient-reported pain on a scale of 0-10 where 0=no pain and 10=worst pain imaginable.
次要结局
- Morphine milligram equivalents(Up to 24 hours postoperatively)
- Incidence of itching(Up to 24 hours postoperatively)
- Incidence of respiratory depression(Up to 24 hours postoperatively)
研究者
Sean C Dowdy, MD
Principal Investigator
Mayo Clinic