Use of Single-Dose Oral Methadone for Pain Management in Outpatient Arthroscopic Hip and Knee Procedures
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Post-op opioid usage
研究概览
简要总结
The goal of this clinical trial is to learn if oral methadone given before surgery works to minimize post-operative pain and opioid usage. The main questions it aims to answer are:
Does oral methadone improve post-operative pain scores as compared to standard treatment? Does oral methadone lead to reduced use of post-operative and post-discharge opioid usage as compared to the current standard treatment?
Researchers will compare oral methadone to a placebo (a look-alike substance that contains no drug) to assess the questions above.
Participants will:
Receive either oral methadone or a look-alike placebo before surgery Receive standard intraoperative and immediate post-operative pain control at the anesthesiologist's discretion Be asked about their pain levels in the recovery area Keep a diary of pain and opioid usage over the first 2 days after surgery
详细描述
STUDY METHOD We plan to perform a double-blinded randomized control study, where the participants, anesthesiologist, data collectors, and study team will be unaware of the intervention offered. Participants will be randomly assigned to the control group (standard intraoperative pain control using short-acting opioids, with drug choice and dosing at the practitioner's discretion) or to the intervention group (a single dose of perioperative oral methadone).
Patients will be recruited and consented to whether they want to participate in the study by a member of the team during a pre-operative clinic visit (Anesthesia START clinic or orthopedic surgery clinic) or on day-of-surgery in the pre-op holding area.
Participants will be randomized to either the control group or treatment group using randomization software. Participants assigned to the intervention group will receive a single dose of oral methadone will be administered in the pre-operative holding area. Dosing will be weight dependent, using 0.15mg/kg ideal body weight (IBW) as a reference; participants weighing less than 50kg will receive 5mg oral methadone, while participants weighing more than 50kg will receive 10mg oral methadone. Participants assigned to the control group will receive an identical-looking placebo sugar pill. A study pharmacist will deliver the appropriate pill to the patient or pre-op nurse in the pre-op holding area on the day of surgery.
Pre-operatively, all participants will complete a survey collecting data on visual analog scale (VAS) pain scores for the 2 weeks leading up to surgery, whether this is different from their baseline pain score at home (if applicable), and pre-operative opioid usage (if applicable). All participants will receive standard-of-care pre-operative non-opioid medications as determined by the orthopedic surgical team if needed.
Intraoperatively, participants will receive either GA or monitored anesthesia care, at the discretion of the anesthesia care team.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •medically optimized participants who will undergo elective arthroscopic knee or hip repair
排除标准
- •pregnant or breastfeeding, age under 18, history of respiratory compromise, allergy to opioids, recipient of pre-operative nerve block
研究组 & 干预措施
Control
placebo sugar pill and standard intraoperative pain control using short-acting opioids, with drug choice and dosing at the practitioner's discretion
干预措施: Placebo (Drug)
Interventional
5mg PO methadone for participants <50kg or 10mg PO methadone for participants >50kg
干预措施: Methadone group (Drug)
结局指标
主要结局
Post-op opioid usage
时间窗: at Post-Anesthesia Care Unit arrival, post-operative 30 minutes, post-op 60 minutes, post-operative day 1, and post-operative day 2
opioid usage, as measured in morphine equivalent doses (MED)
次要结局
- Post-op Pain Score(at Post-Anesthesia Care Unit arrival, post-operative 30 minutes, post-op 60 minutes, post-operative day 1, and post-operative day 2)
研究者
Abigail Song
Co-Investigator
Keck School of Medicine of USC