A Randomized Controlled Trial to Study the Effects of One-time Intra-operative Dosing of Methadone During Laparoscopic or Robotic Hysterectomy in Reducing Opioid Prescription.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Total post-operative opioid requirements in oral morphine milligram equivalents (MME)
研究概览
简要总结
Currently, there is a nationwide epidemic of opioid abuse and overdose deaths. One source of excess opioids is overprescribing in the postoperative period. This study aims to find the optimal pain medication plan during and after laparoscopic hysterectomy to eliminate long-term opioid use.
Given the increasing opioid abuse and over-prescription post-operatively, an effort should be made to determine whether one time dosing of Methadone, a longer opioid analgesics, intra-operatively is an adequate potential in treating postoperative pain after hysterectomy surgeries. The investigators hypothesize that this could minimize the need for additional post-operative and outpatient opioid prescriptions and decrease the adverse effects that are associated with the consumption, including new opioid abuse.
Intervention group will receive methadone intraoperatively while the other group would receive short-acting opioids (standard).
详细描述
Problem:
The relief of moderate to severe postoperative pain in surgeries including abdominal surgeries continues to pose a major therapeutic dilemma. The traditional and most common therapy is the administration of short-acting opioid analgesics, intra-operative and post-operative, at intervals every 3-4 hours. However, the use of opioids with relatively short plasma half-lives at varying intervals may lead to various fluctuating drug concentrations in plasma, and side effects including respiratory, longer hospitalizations, delayed ambulation, inadequate pain relief and potential avenues for abuse. Identifying a more efficient and safer therapy for intraoperative pain analgesia can be helpful in controlling pain requirements in the post-operative setting.
In major inpatient and ambulatory surgeries, intraoperative single-dose methadone, through its unique pharmacology, has been shown to produce better analgesia, reduce opioid use and minimize adverse side effects compared with conventional repeated dosing of short-duration opioids. Additionally, methadone is theorized to be an N-methyl-D-aspartate (NMDA) receptor noncompetitive antagonist, which may contribute to its increase in analgesic potential as compared with fentanyl analogues. Finally, it has been shown to improve ambulation in the post operative anesthesia setting and pain control in chronic pain patients. The study of intra-operative methadone has not been extensively studied for gynecology surgeries, but one study has shown the decrease of mean opioid consumption post operatively after receiving one dose of intra-operative methadone compared to shorter acting opioids in same-day laparoscopic myomectomy. Given the increasing opioid abuse and over-prescription post-operatively, an effort should be made to determine whether one time dosing of longer opioid analgesics intra-operatively is an adequate potential in treating postoperative pain after hysterectomy surgeries and could minimize the need for additional post-operative and outpatient opioid prescriptions.
This study aims at addressing the requirement for postoperative opioid prescription after intraoperative longer acting vs shorter acting opioids in laparoscopic hysterectomy.
Hypothesis:
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Individuals with a uterus
- •Age 18 years old and above
- •Undergoing minimally invasive (laparoscopic or robotic) hysterectomy with ovarian preservation
- •Benign indications for hysterectomy
- •Agreeing to participate
排除标准
- •Chronic pain syndromes patients including fibromyalgia
- •Patients currently on long-term (i.e. for more than three months) opioid use
- •Patients currently on agonist-antagonist medications (e.g. buprenorphine)
- •Patients taking a selective serotonin reuptake inhibitor or monoamine oxidase inhibitor
- •Conversion to laparotomy
- •Allergy or other contraindication to the prescribed medications such as methadone, fentanyl, acetaminophen or oxycodone
- •Severe Obstructive Sleep Apnea (OSA)
- •Pregnant/breastfeeding patients
研究组 & 干预措施
Methadone
Intra-operative single dose IV Methadone (0.25 mg/kg of ideal body weight)
干预措施: Methadone (Drug)
Short-Acting Opioid
Standard intra-operative IV shorter acting opioids
干预措施: Methadone (Drug)
结局指标
主要结局
Total post-operative opioid requirements in oral morphine milligram equivalents (MME)
时间窗: 1 week
Total post-operative opioid requirements in oral morphine milligram equivalents (MME) in first 7 post operative days.
次要结局
- Overall satisfaction with pain control(1 week)
- Number of unplanned returns to emergency room/clinic or patient initiated phone call regarding pain(1 week)
- Mobility and satisfaction of analgesia(Post operative day 1, Post operative day 7)
