NCT01444924已完成2 期
Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery: A Prospective Randomized, Double-blind, Placebo-controlled Trial
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
- 75
- 试验地点
- 1
- 主要终点
- 24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents
研究概览
简要总结
This study is a single-center, randomized, placebo-controlled, double-blind clinical trial. The purpose of this study is to evaluate the impact of pre-operative transverses abdominis plane (TAP) blocks on post-operative analgesia in patients undergoing robotic surgery for gynecologic cancers.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing robotic-assisted surgery under the care of the Division of Gynecologic Oncology at UWHC.
- •Patients must be ≥18 years old.
- •Patients must be English speaking.
- •Patients must have the ability to understand visual and verbal pain scales.
- •ASA physical status 1-3.
排除标准
- •Known allergy to local anesthetics.
- •Immunocompromised.
- •Known history of opioid dependence, as available within the medical record and standard of care pre-operative work-up.
- •Known history of chronic pain disorders.
- •Pregnancy or lactation.
- •Patient is a prisoner or incarcerated.
- •Significant liver disease that would inhibit prescription of opioids.
研究组 & 干预措施
Bupivicaine
Experimental
TAP block with bupivicaine/epinephrine placed prior to surgery.
干预措施: Bupivicaine (Drug)
Placebo
Placebo Comparator
TAP block with placebo placed prior to surgery
干预措施: Placebo (Drug)
结局指标
主要结局
24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents
时间窗: 24 hours
次要结局
- Pain Scores(from 2 hours post-op to the afternoon/evening of post-op day #1)
研究者
研究点 (1)
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