The Impact of Intraoperative Methadone on Postoperative Opioid Use
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Total Postoperative Opioid Use
研究概览
简要总结
This is a single-institution, randomized controlled trial to assess the effectiveness of intraoperative methadone on postoperative opioid use, pain control, and recovery in patients undergoing autologous breast reconstruction. Findings from this trial would inform subsequent perioperative pain protocols and allow the possible integration of intraoperative methadone into multimodal analgesia protocols.
详细描述
Opioid over prescription remains a significant contributor to the opioid crisis in the United States. One major contributor to this epidemic is postoperative opioid prescribing-over 80% of surgical patients receive opioids for postoperative pain, placing many, especially opioid-naive patients, at risk for prolonged use, dependence, and addiction.
Many traditional pain management interventions rely on high doses of short-acting opioids such as hydromorphone and fentanyl. Though effective in the short term, these medications often have fluctuating blood concentration levels, which can lead to ineffective pain control, increased side effects, and higher risk for long-term dependence and chronic use. Despite national efforts to promote better recovery pathways through multimodal pain management plans, significant variation in postoperative opioid prescribing and consumption patterns remains, and over 40% of surgical patients still do not achieve adequate relief of pain.
An alternative solution is intraoperative methadone, a long-acting synthetic opioid with a pharmacologic profile that potentially offers more stable and longer-lasting pain relief. Unlike short-acting opioids, a single dose of methadone given intraoperatively has been shown to be capable of maintaining analgesic levels for up to 24-36 hours, potentially reducing total postoperative opioid requirements.
The use of intraoperative methadone for cardiac, spine, and ambulatory procedures is well-established, demonstrating that methadone leads to significant reductions in perioperative opioid use and pain scores postoperatively without increased risk of opioid side effects. In addition, preliminary data from a 2022 study on DIEP flap patients and a 2024 retrospective cohort study on mastectomy patients both suggest that intraoperative methadone significantly reduces postoperative opioid requirements.
Preliminary retrospective data from revealed that patients receiving intraoperative methadone for autologous breast reconstruction had significantly lower postoperative opioid consumption compared to those who did not receive intraoperative methadone, with a 37.2% reduction in total inpatient opioid use. However, prospective, randomized data in this population is currently lacking.
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
- Double (Participant, Investigator)
盲法说明
The anesthesiology provider assigned to the patient's surgery will be notified of which treatment arm the patient is assigned to by the research coordinator or by the Director of Anesthesia Services on the day of surgery. The reconstructive surgeon and all other hospital staff (e.g. nurses) will be blinded to what treatment arm the patient was assigned.
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
- •Female patients 18 years of age or older
- •Patients undergoing unilateral or bilateral autologous breast reconstruction with abdominally-based free flaps after mastectomy for breast cancer or cancer prophylaxis
排除标准
- •Patients undergoing reoperations such as autologous breast reconstruction as a revision procedure following failed implant-based reconstruction
- •Patients undergoing multiple procedures such as mastectomy and immediate reconstruction
- •Patients with documented chronic opioid use prior to procedure, or chronic pain condition
研究组 & 干预措施
Intraoperative Methadone
the methadone group will receive a single dose of intravenous methadone administered within 30 minutes after induction of anesthesia by the attending anesthesiologist. The standard dose will be 20 mg, except for patients under 60 kg or over 65 years of age, who will receive 15 mg.
干预措施: Methadon (Drug)
结局指标
主要结局
Total Postoperative Opioid Use
时间窗: from the day of surgery until discharge, up to 4 weeks.
To evaluate the impact of intraoperative methadone administration on postoperative opioid use and pain control in patients undergoing autologous breast reconstruction. Total perioperative opioid consumption will be measured in morphine milligram equivalents (MMEs), a standardized measure to quantify the strength of opioid doses compared to morphine. This outcome measure will be assessed from the day of surgery until discharge, up to 4 weeks.
次要结局
- Patient-Reported Pain Scores - Pain Interference Score(from the day of surgery until discharge, up to 4 weeks.)
- Patient-Reported Pain Scores - Visual Analog Scale(from the day of surgery until discharge, up to 4 weeks.)
- Patient-Reported Pain Scores - Patient Pain Management Satisfaction Scale(from the day of surgery until discharge, up to 4 weeks.)
- Length of hospital stay(from the day of surgery until discharge, up to 4 weeks.)
- Proportion of participants utilizing non-opioid analgesics(from the day of surgery until discharge, up to 4 weeks.)
- Opioid-related side effects(from the day of surgery until discharge, up to 4 weeks.)
- Days of non-opioid analgesics use(from the day of surgery until discharge, up to 4 weeks.)
- Time to opioid cessation(from the day of surgery until discharge, up to 4 weeks.)
- Complication Rates(from the day of surgery until discharge, up to 4 weeks.)