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临床试验/NCT03047057
NCT03047057已完成2 期

Effect of Lidocaine Infusion on Acute Rehabilitation After Radical Cystectomy

Assiut University1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2017年3月3日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

IV Lidocaine infusion

干预措施: Lidocaine (Drug)

Control

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Seham Mohamed Moeen Ibrahim

lecturer

Assiut University

研究点 (1)

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