Anesthetic Technique for AV Fistulae Creation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- AV fistula success rate
研究概览
简要总结
This study is being done to compare the two anesthesia techniques which are commonly used in the formation of arteriovenous fistulas: local anesthesia and regional anesthesia. Local anesthesia means that, your doctor will inject numbing medication directly into the tissue or part of your body where the surgery will be done. In this case, the numbing medication will be injected directly into the area where your fistula will be made. In regional anesthesia, the numbing medication will be injected around the nerve (part of the body that gives sensation) for your arm, to make the entire arm numb. The purpose of this study is to compare the three month success rates of AV fistulae created by the two anesthesia techniques.
详细描述
The primary objectives of the study are:
- To evaluate the three-month success rate for AV fistulas constructed while using regional anesthesia against those constructed while using local anesthesia. Success will be evaluated by a dialysis access ultrasound, which will be performed three months after completion of the procedure. Successful will be defined as a mean blood flow of 600 ml/min and above, or receiving hemodialysis using the newly created AV fistula.
- To evaluate the immediate (within 3 days) and long-term complications three months after AV fistula construction under regional anesthesia or local anesthesia.
The secondary objective of the study is to use a short questionnaire survey To assess patient comfort level after creation of AV fistula (e.g. nausea, analgesia).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21-70 years old
- •Able to give informed consent
- •Creation of first time AV fistula
- •Possible 3 month follow up visit
排除标准
- •Repeated AV fistula creation,
- •Allergic to local anesthetic agents,
- •Significant lung and cardiac disease,
- •Infection at the site of regional anesthesia,
- •Pre-existing peripheral nerve damage,
- •Significant bleeding disorders,
研究组 & 干预措施
Local anesthesia
干预措施: regional anesthesia (Procedure)
regional anesthesia
干预措施: local anesthesia (Procedure)
结局指标
主要结局
AV fistula success rate
时间窗: Three months from the day of creation
To evaluate the three-month success rate for AV fistulas constructed while using regional anesthesia against those constructed while using local anesthesia. Success will be evaluated by a dialysis access ultrasound, which will be performed three months after completion of the procedure. Successful will be defined as a mean blood flow of 600 ml/min and above, or receiving hemodialysis using the newly created AV fistula.
次要结局
- Short term comfort level(Within three days of procedure)
- Short term safety, number of post operative complications(Three days after the creation)
研究者
Naum Shaparin
Assistant Professor
Montefiore Medical Center