Peripheral Nerve Blocks for Upper Leg Amputations
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Peripheral Nerve Block Success as a Primary Anesthetic
研究概览
简要总结
Surgery performed with nerve blocks and sedation may be safer and provide better pain control compared to general anesthesia and opioid therapy in high-risk patient populations such as elderly and troubled with peripheral vascular disease, diabetes, hypertension, coronary artery disease, and chronic obstructive pulmonary disease (COPD).
详细描述
Avoidance of general anesthesia in certain high-risk patient populations may have additional benefits beyond improved postoperative pain scores and analgesic consumption. The primary objective of this research will be to evaluate the ability of the femoral, sciatic, lateral femoral cutaneous nerve (LFCN), and obturator blocks to provide surgical anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Patients undergoing above-the-knee amputation or knee disarticulation
- •Ability to understand and provide informed consent
排除标准
- •Patient refusal or inability to provide informed consent
- •True allergy, not sensitivity, to any of the following substances:
- •- Local anesthetics
- •- Propofol or other sedative agents
- •- General anesthetic agents
- •Pregnancy
- •Severe hepatic impairment
- •Evidence of infection at or near the proposed needle insertion site
- •Any sensorimotor deficit, whether acute or chronic, as determined by the PI
- •Chronic use of opioid medication
研究组 & 干预措施
Peripheral nerve block
Prospectively evaluate peripheral nerve blocks as a primary anesthetic in the setting of above-the-knee amputations.
All enrollees will be administered Intravenous sedatives using propofol or dexmedetomidine and have ultrasound-guided femoral and sciatic nerve blocks placed per current practice at research site. Single-injection obturator nerve blocks and lateral femoral cutaneous nerve blocks will also be performed.
干预措施: Peripheral nerve block (Procedure)
Peripheral nerve block
Prospectively evaluate peripheral nerve blocks as a primary anesthetic in the setting of above-the-knee amputations.
All enrollees will be administered Intravenous sedatives using propofol or dexmedetomidine and have ultrasound-guided femoral and sciatic nerve blocks placed per current practice at research site. Single-injection obturator nerve blocks and lateral femoral cutaneous nerve blocks will also be performed.
干预措施: Intravenous Sedatives (Drug)
Peripheral nerve block
Prospectively evaluate peripheral nerve blocks as a primary anesthetic in the setting of above-the-knee amputations.
All enrollees will be administered Intravenous sedatives using propofol or dexmedetomidine and have ultrasound-guided femoral and sciatic nerve blocks placed per current practice at research site. Single-injection obturator nerve blocks and lateral femoral cutaneous nerve blocks will also be performed.
干预措施: Lateral femoral cutaneous nerve blocks (Procedure)
Peripheral nerve block
Prospectively evaluate peripheral nerve blocks as a primary anesthetic in the setting of above-the-knee amputations.
All enrollees will be administered Intravenous sedatives using propofol or dexmedetomidine and have ultrasound-guided femoral and sciatic nerve blocks placed per current practice at research site. Single-injection obturator nerve blocks and lateral femoral cutaneous nerve blocks will also be performed.
干预措施: Obturator nerve blocks (Procedure)
结局指标
主要结局
Peripheral Nerve Block Success as a Primary Anesthetic
时间窗: Intraoperative period (typically one to three hours)
次要结局
- Mortality(Changes from baseline through 30 days post-operative.)