Efficacy of Continuous Infusion of Local Anesthesia After Radical Cystectomy: A Randomized, Double Blind, Placebo Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Narcotic requirement
研究概览
简要总结
This randomized phase IV trial studies how well the continuous infusion of ropivacaine hydrochloride works in reducing pain after surgery in patients with bladder cancer. Ropivacaine hydrochloride is an anesthetic drug used to decrease pain by numbing an area of the body without putting the patient to sleep. Continuous infusion of ropivacaine hydrochloride may reduce pain and improve the quality of life for patients after bladder surgery.
详细描述
PRIMARY OBJECTIVES:
I. To determine if continuous infusion of local anesthesia (CILA) decreases post-operative pain after radical cystectomy (RC).
II. To determine if CILA reduces narcotic requirements after RC.
SECONDARY OBJECTIVES:
I. To determine if CILA decreases length-of-stay after RC. II. To determine if CILA improves patients satisfaction with post-operative pain control after RC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing elective open radical cystectomy
- •Ability to understand and the willingness to sign a written informed consent
排除标准
- •Allergy or adverse reaction to ropivacaine (ropivacaine hydrochloride) or any amide type of local anesthesia
- •Allergy or adverse reaction to local anesthesia catheter
- •Additional surgery at the same time as RC (e.g. nephroureterectomy)
- •Coagulopathy
- •Thrombocytopenia
- •Local or systemic infection
- •Pregnancy
- •Chronic hepatic disease
- •Use of type III antiarrhythmics (e.g. amiodarone)
- •History of chronic pain and/or daily opioid use
研究组 & 干预措施
Arm I (ropivacaine hydrochloride)
Patients receive ropivacaine hydrochloride IV continuously over 72 hours after radical cystectomy.
干预措施: Questionnaire Administration (Other)
Arm I (ropivacaine hydrochloride)
Patients receive ropivacaine hydrochloride IV continuously over 72 hours after radical cystectomy.
干预措施: Ropivacaine Hydrochloride (Drug)
Arm II (placebo)
Patients receive normal saline (placebo) IV continuously over 72 hours after radical cystectomy.
干预措施: Placebo (Other)
Arm II (placebo)
Patients receive normal saline (placebo) IV continuously over 72 hours after radical cystectomy.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Narcotic requirement
时间窗: Up to 72 hours after surgery
Total narcotic dose after surgery until 72 hours will be analyzed as continuous variables and will be compared with the one sided t-test in an intention-to-treat manner.
次要结局
- Length of hospitalization(Up to 30 days after surgery)