Bupivacaine With Epinephrine vs Sham Injections During Endoscopic Sinus Surgery: a Double Blind, Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Boezzart bleeding score
研究概览
简要总结
Endoscopic sinus surgery (ESS) is a common otolaryngologic procedure that aims to remove the partitions that separate the sinus cavities, remove inflamed tissue, and optimize the sinuses for topical medication use. In this procedure, the surgeon will inject a combination of drugs, local anesthetics, and vasoconstrictors, to reduce bleeding and improve visualization. However, previous studies have shown similar results when injected with only saline. In this study, investigators want to determine if the injection of local anesthesic+vasoconstrictor compared to no injection at all makes any difference in improving the surgeon's visualization during an ESS.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19 years or older
- •Scheduled for primary ESS (including septoplasty)
排除标准
- •Cystic fibrosis
- •Systemic vasculitis or any bleeding disorders
- •Known or suspected hypersensitivity to bupivacaine or epinephrine
- •Previous sinus surgery
- •Inhaled drug use (i.e., cocaine) in the preceding 6 months
- •Nasal tumors
- •Patients on antiarrhythmics.
- •Patients with history of severe liver illness.
- •Patients identified as high-risk for complications during preoperative assessment with the anesthesiologist (e.g. untreated hypertension, ischemic heart disease, cerebral vascular insufficiency, heart block, peripheral vascular disorder, uncontrolled hyperthyroidism and diabetes)
研究组 & 干预措施
Injection
- Injection 0.25% bupivacaine with 1:200,000 epinephrine
干预措施: Sensorcaine with Epinephrine (Drug)
Sham injection
- Sham injection (only puncture, no injecting anything)
干预措施: Sham injection (Other)
结局指标
主要结局
Boezzart bleeding score
时间窗: throughout study completion, one day study visit
Change in mean surgical field quality as determined by the Boezzart bleeding score. Boezaart score of 0 indicates no bleeding, whereas the maximum score of 5 indicates severe bleeding (constant suctioning required).
次要结局
- Mean arterial pressure (MAP)(throughout study completion, one day study visit)
- Postoperative pain(throughout study completion, one day study visit)
- Total blood loss(throughout study completion, one day study visit)
- Surgical time(throughout study completion, one day study visit)
- Postoperative bleeding(throughout study completion, one day study visit)
研究者
Amin Javer
Clinical Professor
St. Paul's Hospital, Canada