Effect of Lidocaine Infusion on Acute Rehabilitation After Radical Cystectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Postoperative return of gastrointestinal (GI) function
研究概览
简要总结
Radical cystectomy (RC) remains the gold standard for treatment of patients with muscle invasive bladder cancer, or recurrent high grade non-muscle invasive bladder cancer. Nowadays, enhanced recovery pathway is used to decrease morbidity and improve acute rehabilitation after RC. Postoperative ileus is the most frequent reason for prolonged hospital stay following cystectomy.
详细描述
Radical cystectomy remains the gold standard for treatment of patients with muscle invasive bladder cancer, or recurrent high grade non-muscle invasive bladder cancer. The high rates of morbidity and mortality reflect the fact that the majority of patients undergoing this procedure are elderly patients with multiple comorbidities. Postoperative ileus is the most frequent reason for prolonged hospital stay following cystectomy. To reduce the risk of ileus, prokinetics such as metoclopramide should be used postoperatively. Local anesthetics exert their actions as local anesthesia and antiarrhythmic through Na channels blocking but still have many other important actions through other receptors (e.g., m1 muscarinic receptors) that occur at very low plasma levels compared to levels needed for Na channels blocking, one of these actions is the anti-inflammatory effect against surgical stress response. Several randomized studies found that i.v. lidocaine shortens duration of postoperative ileus and some of it reported decreased postoperative pain with i.v. lidocaine, so they recommended i.v. lidocaine as a safe, simple, and less invasive method for management of postoperative ileus and equal to postoperative epidural analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •45-75 yr ASA class I,II, and III Elective radical cystectomy
排除标准
- •Allergy to the study medication, pre-existing chronic pain at any site requiring treatment, Psychiatric disease, hepatic or renal impairment, seizure disorder requiring medication within the previous 2 years
研究组 & 干预措施
Lidocaine
IV Lidocaine infusion
干预措施: Lidocaine (Drug)
Control
IV normal saline infusion
干预措施: IV normal saline (Drug)
结局指标
主要结局
Postoperative return of gastrointestinal (GI) function
时间窗: 15 day
Time to the first defecation
次要结局
- Postoperative Pain(72 hours after surgery)
研究者
Seham Mohamed Moeen Ibrahim
lecturer
Assiut University
