Preemptive Analgesia With Pregabalin in Heart Surgery: a Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- Pain perception in visual analog scale (0 means no pain and 10 is the most severe pain) at 72 hour post operative
研究概览
简要总结
BACKGROUND: Postoperative pain after cardiac surgery has high incidence and is associated with worse morbidity. Pregabalin is a new antiepileptic drug used in patients with chronic pain and has been studied even more in postoperative. OBJECTIVE: Evaluate whether preemptive pregabalin use compared with placebo decreases pain perception in patients undergoing cardiac surgery in the first 24 hours and 2 months after hospital discharge; evaluate analgesic consumption in the immediate postoperative period; evaluate differences in blood gas parameters between groups; evaluate anesthetic recovery by QoR-40; assess incidence of serious adverse events (reintubation and mental confusion); incidence of delirium through the CAM-ICU questionnaire; assess adverse drug events (nausea, vomiting, pharmacodermia, allergic reactions). METHOD: Randomized, triple-blind, placebo-controlled clinical trial. EXPECTED RESULTS: Postoperative pain control with a drug that could cause fewer side effects, may lead to faster clinical improvement, fewer medications and fewer procedures, and lower healthcare costs with a decrease in intensive care unit (ICU) stay.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who will undergo median sternotomy due to the need for cardiac surgery (valvular or myocardial revascularization);
- •Patients between 18 and 70 years old;
- •Patients able to swallow tablets and agree to participate in this clinical trial.
排除标准
- •Patients with chronic renal failure with creatinine clearance less than or equal to 30 mL/min;
- •Patients with known hypersensitivity to pregabalin;
- •Hemodynamically unstable patients using vasoactive drugs the day before surgery;
- •Unconscious and/or sedated patients, or without cognitive discernment to use the visual analog scale;
- •Patients previously submitted to sternotomy; emergency surgery;
- •Patients with neurological diseases; anticonvulsant drug users.
研究组 & 干预措施
pregabalin
干预措施: Pregabalin 150mg (Drug)
placebo
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Pain perception in visual analog scale (0 means no pain and 10 is the most severe pain) at 72 hour post operative
时间窗: 72 hours post operative
Analgesic opioids consumption at 72 hours post operative
时间窗: 72 hours post operative
次要结局
- Pain perception in visual analog scale (0 means no pain and 10 is the most severe pain) and analgesic opioids consumption at month 2 post operative(Month 2 post operative)
- Partial pressure of oxygen in millimeter of mercury (mmHg)(03 hours, 06 hours, 12 hours and 24 hours post operative)
- Incidence of delirium by Confusion Assessed Method fo the Intensive Care Unity (CAM-ICU)(24 hour post operative)
- Number of participants with treatment-related adverse drug events (nausea, vomiting, pharmacodermia, allergic reactions) assessed by Common Terminology Criteria for Adverse Events (CTCAE v5.0)(72 hour post operative)
- Partial pressure of carbon dioxide in millimeter of mercury (mmHg)(03 hours, 06 hours, 12 hours and 24 hours post operative)
- Arterial blood potential of hydrogen (pH)(03 hours, 06 hours, 12 hours and 24 hours post operative)
- Oxygen saturation in percentage (%)(03 hours, 06 hours, 12 hours and 24 hours post operative)
- Anesthetic recovery by Quality of Recovery 40-item questionnaire (QoR-40 - 40 items questionnaire each item ranging from 1 to 5 being 1 very poor and 5 excellent)(24 hour post operative)
- Incidence of serious adverse events (reintubation, infection, bleeding, AKI)(72 hour post operative)
研究者
Bruno Robalinho Cavalcanti Barbosa
Principal Investigator
InCor Heart Institute