Effect of Post-Induction Methadone on Postoperative Pain, Opioid Use, and Recovery in Spine Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Perioperative Opioid use in morphine equivalents (ME)
研究概览
简要总结
The goal of this prospective cohort study is to evaluate the clinical effects of post-induction methadone on perioperative pain control, opioid requirements, and recovery outcomes in adult patients undergoing elective spine surgery, with the goal of improving postoperative analgesia and enhancing recovery efficiency. The main questions it aims to answer are the perioperative pain control and opioid requirements between the two groups.
Post-induction methadone can offer equivalent or improved pain control following major spine procedures and reduce intra- and postoperative opioid requirements, improve perioperative pain control and shorten PACU stay.
Researchers will compare perioperative opioid use (morphine equivalents (ME), during the intraoperative and postoperative periods (PACU and 24-hour totals) between the standard intraoperative opioid regimen group and the methadone group.
Patients will be randomized preoperatively to one of two groups: (both groups will receive additional multimodal pain control including opioids, not including methadone, as needed) Standard intraoperative opioid regimen (control) Methadone 0.2 mg/kg (max 20 mg)
If the patient is in the methadone group, the patient will receive a predetermined dose of Methadone (0.2mg/kg) intravenously after induction (they are given medications to sleep for surgery). They will proceed with surgery, and all patients will receive standard of care management regardless of whether they receive Methadone or not. Following the surgery, all study participants will be asked at set times about their pain level and, 24 hours after the surgery, will be asked if they are satisfied with their pain management for the surgery. Data regarding their clinical progression and pain control/pain medication requirements will be collected for the duration of the hospitalization.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing elective spine surgery (e.g., fusion, decompression)
- •Expected postoperative inpatient admission
- •Able to provide informed consent
- •Patients with opioid use disorder (OUD) may be included if on stable maintenance therapy
排除标准
- •Use of regional or neuraxial anesthesia
- •Contraindication to methadone use (e.g., prolonged QTc, allergy, severe hepatic disease)
- •Cognitive impairment precluding consent or accurate pain scoring
结局指标
主要结局
Perioperative Opioid use in morphine equivalents (ME)
时间窗: Perioperative until 72 hours postoperative
perioperative opioid use (morphine equivalents (ME): intraoperative, PACU, and 72-hour totals)
次要结局
- Change in numeric rating scale (NRS) pain scores(PACU arrival to 24 hours postoperative)
- Time in PACU(PACU arrival to PACU discharge (determined by time of PACU discharge note entry). Assess up to 24 hours postoperatively.)
- Hospital Length of Stay(Hospital admission to hospital discharge. Measured in days and determined as the time from admission for surgery to hospital discharge. Assess up to 30 days postoperatively)
- Incidence of respiratory depression(Measured from time of PACU admission until 72 hours postoperatively.)
- Incidence of Postoperative nausea and vomiting(Assessed postoperatively up to 72 hours after documented PACU admission time)
- Patient Satisfaction(Postoperative until 24 hours postoperative)
研究者
Brandon Knopp
Principal Investigator
University of Kentucky