Opioid-free Analgesia After Outpatient General Surgery: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Percentage of Screened Participants Who Were Eligible to Participate in the Study
研究概览
简要总结
North America is facing an opioid epidemic fueled by surgeons, who are the second largest subgroup of physicians involved in opioid prescribing. Surgery often serves as the initial event for opioid-naïve patients to obtain a prescription for opioids and spiral into misuse and addiction. From the perspective of perioperative care clinicians, the answer to the opioid crisis may be using opioid-free analgesia. However, the number of comparative studies in this field is limited and existing small trials do not reflect current standards of care in North America. Lack of evidence means that the decision to prescribe opioids after outpatient surgery largely depends on surgeon preference and healthcare culture. Hence, there is an urgent need for a robust randomized controlled trial (RCT) to guide clinical decision-making. The feasibility and optimal design of this RCT should be informed by a pilot trial. The overarching goal of this pilot RCT is to investigate the feasibility of conducting a full-scale RCT to assess the comparative-effectiveness of opioid versus opioid-free analgesia after outpatient general surgery.
详细描述
This study will be a pragmatic, parallel, two-group, assessor-blind, pilot RCT. The investigators aim to recruit 80 adult patients at two tertiary hospitals in Montreal. Eligibility criteria will span outpatient procedures in abdominal and breast surgery. Patients are randomized on a 1:1 ratio to treatment with either opioid (standard care) or without opioid (only non-opioid analgesics). Patients will be followed up for 3 months after surgery; postoperative day (POD) 1 to POD 7 and at 2, 3 and 4 weeks after surgery, and at 3 months. Assessments will include postoperative pain, physical and mental function, adverse drug events, prolonged opioid use and opioid misuse. Feasibility outcomes will include the number of patients screened, consented and randomized, adherence with treatment and completion of follow-up. Data from this pilot study will inform the calculation of sample size requirements for the full-scale RCT. An embedded qualitative study will be conducted to help optimize trial design based on clinicians' and patients' perspective.
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)
盲法说明
Patient-reported outcomes and treatment adherence data will be collected via self-administered electronic questionnaires distributed using REDCap (http://project-redcap.org/) and completed by patients via smartphone, tablet or personal computer. Electronic outcome data will be transmitted directly to the REDCap database and verified by a blinded assessor. Adherence data will be verified by unblinded study staff. Patients who are not computer savvy, have limited access or prefer non-electronic assessment will complete the questionnaires via telephone interviews with a blinded assessor; in this case, data will be recorded in paper forms and subsequently transferred to the REDCap database. Outcome data that are not patient-reported (e.g. postoperative complications, unplanned healthcare utilization, chronic opioid use), will be obtained from medical records by a blinded 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
- •Adult patients (>18 yo) undergoing outpatient surgery
- •Abdominal surgery (i.e. cholecystectomies, hernia repairs, ovarian cystectomies, salpingectomies)
- •Breast surgery (i.e. lumpectomies, partial and complete mastectomies, axillary node dissections)
排除标准
- •All patients
- •Intraoperative or early postoperative complications (i.e. diagnosed in the Post-Anesthesia Care Unit (PACU)) that require postoperative hospital stay
- •Contraindications to any of the drugs used in the trial
- •Difficult to be reached after surgery
- •Inability to provide written informed consent
研究组 & 干预措施
Opioid analgesia
干预措施: Opioid analgesics (Drug)
Opioid-free analgesia
干预措施: Non-opioid analgesics (Drug)
结局指标
主要结局
Percentage of Screened Participants Who Were Eligible to Participate in the Study
时间窗: 4 months
At least 70% of patients undergoing the outpatient general surgery procedures of interest (screened participants) are eligible to be randomized.
Percentage of Surgeons Agreeing and Adhering to Patient Randomization
时间窗: 4 months
At least 90% of the surgeons who agreed to have their patients randomized comply with the agreement (i.e. not change their minds).
Percentage of Eligible Patients Agreeing to Participate
时间窗: 4 months
At least 50% of eligible patients agree to participate in the study and are randomized.
Percentage of Randomized Patients Complying With Allocated Treatment
时间窗: 4 months
At least 80% of the randomized patients comply with their allocated treatment (i.e. will take their pain medications as prescribed).
Percentage of Randomized Patients Completing the 30-day Postoperative Outcome Assessment
时间窗: 4 months
At least 80% of the randomized patients complete outcome assessment at 30 days after surgery.
Percentage of Missing Data Among All Questionnaires Distributed to Patients Who Completed the Assessments
时间窗: 4 months
Among all questionnaires distributed to patients who complete outcome assessments, the proportion of missing data (i.e. non-response to questionnaires) is less than 10%.
Percentage of Missing Data Among All Questionnaire Items Distributed to Patients Who Completed the Assessments
时间窗: 4 months
Among patients who complete outcome assessments, the proportion of missing data is less than 10% (i.e. non-response to specific questionnaire items).
次要结局
- Postoperative Pain(30 days.)
- Time to Stopping Pain Medication(30 days.)
- Postoperative Health Status(Weeks 1, 2, 3 and 4 after surgery.)
- Opioid Side-effects(Postoperative days 1 to 7, weeks 2, 3 and 4 after surgery)
- Rate of Opioid Misuse(4 weeks)
- Postoperative Complications Classification(30 days.)
- Rate of Unplanned Healthcare Utilization(30 days.)
- Rate of Adverse Drug Events(30 days after surgery)
- Rate of Prolonged Opioid Use(3 months)
- Comprehensive Complication Index at 30-day(30 days)
研究者
Julio F Fiore Jr
Assitant Professor (McGill)
McGill University Health Centre/Research Institute of the McGill University Health Centre