Peri-Operative Pregabalin for Reducing opIoid Consumption AfTer Cardiac surgEry: A Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Cumulative opioid consumption
研究概览
简要总结
OPIATE is a double-blinded randomized controlled trial (RCT) comparing pregabalin in addition to usual care to usual care alone for reducing post-operative opioid consumption in patients undergoing on-pump cardiac surgery. Patients will be randomized in a 1:1 ratio to receive either pregabalin (300 mg pre-operatively + 75 mg post-operatively twice daily until discharge or 5 days) in addition to usual care or matching placebos in addition to usual care. The aim of the trial is to show that pregabalin is superior to usual care (i.e. a superiority trial).
详细描述
By administering oral pregabalin to patients before and after cardiac surgery for pain relief, we aim to reduce the amount of opioids they will require for pain relief and reduce opioid-related side effects that they may experience after surgery. Participants will be randomly assigned to receive either pregabalin in addition to usual care or usual care alone. Participants in the pregabalin group will receive two 150 mg pregabalin capsules (300 mg total dose) within 2 hours before surgery and a 75 mg pregabalin capsule twice daily after surgery until discharge from hospital to a maximum of 5 days after surgery. Participants in the usual care group will receive two placebo study capsules within 2 hours before surgery and a placebo capsule twice daily after surgery until discharged from hospital to a maximum of 5 days after surgery. OPIATE will be the largest clinical trial of pregabalin in cardiac surgery with results that are expected to set new post-operative pain management guidelines to encourage the widespread use of pregabalin in cardiac patients.
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)
盲法说明
Matching placebo capsules
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
- •≥ 18 years of age
- •Undergoing cardiac surgery with median sternotomy
- •Provide written informed consent
排除标准
- •Use of opioids or cannabis products in the past 30 days
- •Daily use of pregabalin or gabapentin within 7 days of randomization
- •Intravenous drug user
- •Have a hypersensitivity or allergy to pregabalin
- •History of previous cardiac surgery
- •Undergoing minimally invasive surgery
- •Emergency surgery
- •Severe renal impairment (creatinine > 250 μmol/L)
- •Unable to swallow study medications
- •Pregnant or breast feeding
研究组 & 干预措施
Pregabalin + Usual Care
300 mg pregabalin taken orally within 2 hours before surgery and 75 mg pregabalin taken orally twice daily after surgery beginning after successful extubation (day after surgery or later) until discharge or 5 days, whichever comes first. Participants will also receive standard pain management.
干预措施: Pregabalin 300 mg (Drug)
Pregabalin + Usual Care
300 mg pregabalin taken orally within 2 hours before surgery and 75 mg pregabalin taken orally twice daily after surgery beginning after successful extubation (day after surgery or later) until discharge or 5 days, whichever comes first. Participants will also receive standard pain management.
干预措施: Pregabalin 75 mg (Drug)
Pregabalin + Usual Care
300 mg pregabalin taken orally within 2 hours before surgery and 75 mg pregabalin taken orally twice daily after surgery beginning after successful extubation (day after surgery or later) until discharge or 5 days, whichever comes first. Participants will also receive standard pain management.
干预措施: Usual Care (Other)
Placebo + Usual Care
Placebo taken orally within 2 hours before surgery and placebo taken orally twice daily after surgery beginning after successful extubation (day after surgery or later) until discharge or 5 days, whichever comes first. Participants will also receive standard pain management.
干预措施: Pregabalin 300 mg Placebo (Drug)
Placebo + Usual Care
Placebo taken orally within 2 hours before surgery and placebo taken orally twice daily after surgery beginning after successful extubation (day after surgery or later) until discharge or 5 days, whichever comes first. Participants will also receive standard pain management.
干预措施: Pregabalin 75 mg Placebo (Drug)
Placebo + Usual Care
Placebo taken orally within 2 hours before surgery and placebo taken orally twice daily after surgery beginning after successful extubation (day after surgery or later) until discharge or 5 days, whichever comes first. Participants will also receive standard pain management.
干预措施: Usual Care (Other)
结局指标
主要结局
Cumulative opioid consumption
时间窗: After surgery until discharge from hospital or 5 days, whichever is first.
Dose of opioids consumed (in morphine equivalents) by participants
Daily opioid consumption
时间窗: Each postoperative day, beginning on postoperative day 1 and ending on the day of discharge from hospital or postoperative day 5, whichever is first.
Dose of opioids consumed (in morphine equivalents) by participants
次要结局
- Average postoperative pain(Average of scores after surgery until discharge from hospital or 5 days, whichever is first.)
- Cumulative consumption of antiemetic medications(After surgery until discharge from hospital or 5 days, whichever is first.)
- Daily consumption of antiemetic medications(Each postoperative day, beginning on postoperative day 1 and ending on the day of discharge from hospital or postoperative day 5, whichever is first.)
- Time to extubation(Within the first 5 days after surgery)
- Mobility(Within the first 5 days after surgery)
- Delirium(Starting the second day after surgery and ending after 5 days or 3 days of negative tests.)
- Major adverse cardiovascular events(Within the first 5 days after surgery)
- Death(Within the first 5 days after surgery)
- Myocardial infarction(Within the first 5 days after surgery)
- Stroke(Within the first 5 days after surgery)
- Daily postoperative pain(Each postoperative day, beginning on postoperative day 1 and ending on the day of discharge from hospital or postoperative day 5, whichever is first.)
研究者
Andre Lamy
Cardiac Surgeon
Hamilton Health Sciences Corporation