A Randomized Controlled Trial to Determine if Pre- and Post- Operative Regional Pain Control (Transversus Abdominis Plane Block) With Ropivacaine Versus Placebo Leads to Lower Anesthetic and Narcotic Dosing, and Alters Pain Scores
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain Scores
研究概览
简要总结
A randomized controlled trial to determine if pre- and post- operative regional pain control (transversus abdominis plane block) with ropivacaine versus placebo leads to lower anesthetic and narcotic dosing, and alters pain scores.
This study plans to learn more about regional anesthesia and pain control during abdominal surgery. The study will gather data about the effectiveness of continuous catheter infusion of local anesthetic after an abdominal operation. Outcomes include pain scores, IV pain medicine requirements, and delirium.
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)
盲法说明
"Study drug" label of drug
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >=50 years.
- •Subjects will be undergoing an elective intra-abdominal or abdominal wall operation, including pelvic operations. Surgery specialties included are general surgery, surgical oncology, urology, gynecology, plastic surgery.
排除标准
- •Subjects with a history of dementia or aphasia, as visual analog scale and confusion assessment will be unreliable.
- •Patients with an epidural or spinal catheter block.
- •Patients who do not speak English so that a language barrier is not confused with VAS scoring or confusion.
- •Patients who are abusing alcohol defined by a high AUDIT score (>8) will be excluded.
- •History of bipolar disorder or a psychotic disorder (such as a psychotic major depression, schizophrenia, schizoaffective disorder, or psychosis in Alzheimer's disease or other dementia).
- •Patients with a documented allergy to ropivacaine or other sodium channel blockers.
研究组 & 干预措施
Ropivacaine
Participants will have bilateral TAP catheters placed along with continuous infusion of ropivacaine.
干预措施: Ropivacaine HCL (Drug)
Placebo
Participants will have bilateral TAP catheters placed along with continuous infusion of placebo.
干预措施: sodium chloride (Drug)
结局指标
主要结局
Pain Scores
时间窗: Days 0-7 following the operation
Pain scores from the visual analog scale
次要结局
- Amount of anesthetic(During the operation)
- Amount of narcotic administered postoperatively(Days 0-7 postop)