Comparative Effectiveness of Opioid Versus Opioid-free Post-discharge Analgesia After Outpatient Breast Surgery: A Protocol for a Randomized Controlled Trial (PAIN-Alt Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 540
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
North America is experiencing a crisis of opioid use and abuse, partially caused by excessive prescribing by doctors. People often receive their first opioid prescription for pain treatment after outpatient breast surgery (i.e., surgery to remove all or parts of the breast(s), where patients leave the hospital the same day). Many patients misuse these drugs and become addicted. Additionally, many of the opioid pills prescribed to patients are left unused and may be misused by family members, friends, or other community members. To prevent this problem, surgeons can avoid prescribing opioids by prioritizing opioid-free analgesia (i.e., pain treatment using only non-opioid interventions). Prescribing only non-opioid pain medications after surgery is very common in many countries outside of North America; however, few studies have assessed whether opioid-free analgesia is as effective as opioid analgesia after breast surgery. Therefore, the main question driving this study is: For patients who undergo outpatient breast surgery, is pain treatment without opioids as good as pain treatment with opioids?
The proposed trial will compare two groups of patients: one group will receive opioids to treat pain after surgery, while the other group will receive only non-opioid medications. The impact of these different medication strategies will be measured on pain intensity, pain interference with daily activities, medication side effects, and other outcomes. An expert team of scientists, surgeons, pain specialists, nurses, and patients has been assembled to maximize the success of this study. The results will provide important information to guide surgeons' decisions to prescribe (or not to prescribe) opioids. If opioid-free analgesia is found to be effective, doctors may be able to substantially reduce opioid prescribing after breast surgery and prevent more people from misusing opioids.
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 (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
- •Undergoing mastectomy (i.e., total, modified radical, radical, or skin/nipple sparing) or lumpectomy (i.e., excisional biopsy, partial or segmental mastectomy, oncoplastic breast-conserving surgery) for malignant (cancer) and non-malignant diseases (i.e., ductal carcinoma in situ)
- •Planned discharge on the day of the operation.
排除标准
- •Immediate breast reconstruction, i.e., implant, tissue-expander, or autologous/flap-based (often leads to higher levels of pain and analgesia requirements)
- •Contraindications to the drugs used in the trial in accordance with Health Canada Monographs (i.e., opioid use disorder, pregnancy, breastfeeding, heart failure, allergy/hypersensitivity, peptic ulcer, bleeding disorders, renal or liver impairment)
- •Taking opioids preoperatively
- •Cognitive impairment precluding patient-reported outcome assessment
- •Need for postoperative hospitalization decided before randomization (i.e., same-day discharge cancelled for medical [e.g., intra-operative complications] or non-medical reasons [e.g., lack of support at home]).
结局指标
主要结局
Pain intensity
时间窗: Postoperative days 1 to 7.
Pain intensity will be measured using the Brief Pain Inventory-Short Form (BPI), a self-reported pain questionnaire developed by the World Health Organization (WHO). In this questionnaire, pain intensity is measured across four domains (worst, least, on average, and currently). Aggregated scores of pain intensity range from 0-10, with higher scores representing worse outcomes.
Pain interference
时间窗: Postoperative days 1 to 7.
Pain interference will be measured using the Brief Pain Inventory-Short Form (BPI), a self-reported pain questionnaire developed by the World Health Organization (WHO). In this questionnaire, pain interference is measured across seven domains (mood, work, general activity, walking, relationships, enjoyment of life, and sleep). Aggregated scores of pain interference range from 0-10, with higher scores representing worse outcomes.
次要结局
- Physical and Mental Health Status(Postoperative weeks 1, 2, 3, and 4, postoperative month 3 and 6.)
- 30-day postoperative complications(Up to 30 days after surgery.)
- 30-day unplanned healthcare utilization(Up to 30 days after surgery.)
- Time to stopping pain medication(Up to 30 days after surgery.)
- Opioid misuse(Postoperative weeks 1, 2, 3, and 4, postoperative month 3 and 6.)
- Adverse drug events(Up to 30 days after surgery.)
- Chronic postsurgical pain(Up to 6 months after surgery.)
- Persistent opioid use(Up to 6 months after surgery.)
- Satisfaction with pain management(Postoperative day 7.)
研究者
Julio F Fiore Jr
Associate Professor, Scientist
McGill University Health Centre/Research Institute of the McGill University Health Centre