Comparison of Obturator Nerve Blockade and Neuromuscular Blockade for the Prevention of Adductor Spasm in Patients Undergoing Transurethral Resection of Bladder Tumors.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of Patients With Incidence of Intraoperative Adductor Spasm
研究概览
简要总结
Patients diagnosed with posterolateral bladder tumors will be invited to participate in the study. Subjects will be randomized to receive an ultrasound-guided obturator block or a neuromuscular blocking agent after the induction of general anesthesia in an attempt to block the obturator reflex during surgery.
详细描述
The purpose of this research is to compare the incidence of adductor spasm in patients undergoing general anesthesia with neuromuscular blocking agents versus obturator block. Transurethral resection of bladder tumor(s) (TURBT) is a commonly performed procedure to diagnose and treat bladder cancer. The obturator nerve is located lateral to the bladder wall in the pelvis prior to innervating the adductor muscles of the thigh. Depending on the location of the tumor(s), electrocautery or surgical stimulation may result in stimulation of the obturator nerve, resulting in adduction of the leg, which is called the adductor reflex or spasm. This may occur violently and unexpectedly, and result in bladder perforation, bleeding, or cancer dissemination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years of age
- •Planned TURBT for unilateral or bilateral posterolateral bladder tumors
- •Ability to understand and provide informed consent
排除标准
- •Patient refusal or inability to provide informed consent
- •True allergy, not sensitivity, to local anesthetics
- •True allergy, not sensitivity, Propofol
- •True allergy, not sensitivity, general anesthetic agents
- •Pregnancy
- •Severe hepatic impairment
- •Evidence of infection at or near the proposed needle insertion site
- •Any sensorimotor deficit of the lower extremity, whether acute or chronic
- •Inability to walk without assistance
- •Lower extremity joint replacement surgery in the preceding six months
研究组 & 干预措施
Obturator block
Comparing the incidence of adductor spasm in patients undergoing general anesthesia with obturator block.
干预措施: Obturator block (Drug)
Neuromuscular block
Comparing the incidence of adductor spasm in patients undergoing general anesthesia with neuromuscular blocking agents.
干预措施: Neuromuscular block (Drug)
结局指标
主要结局
Number of Patients With Incidence of Intraoperative Adductor Spasm
时间窗: intraoperative
Nerve Integrity Monitor will be used to detect adductor spasm and below are listed the numbers or patients with increased incidence of adductor spasm.
次要结局
- Number Patients With Increased Risk of Falling(Changes from baseline (pre-op) to 72 hours post-operative)
- Number of Patients With Incidence of Leg Weakness(Changes from baseline (pre-op) to 72 hours post-operative)