Optimizing Catheter Insertion Technique for Ultrasound-guided Continuous Peripheral Nerve Blocks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Onset time of sensory anesthesia
研究概览
简要总结
Continuous peripheral nerve blocks (CPNB; also known as "perineural" catheters) provide target-specific pain control for a variety of surgeries. There has been increasing interest in the use of ultrasound guidance for regional anesthesia, and many techniques using ultrasound alone for perineural catheter insertion have been described. Catheters may be placed at various points along the brachial plexus (for upper extremity procedures) or in proximity to the femoral and/or sciatic nerve (for lower extremity procedures). To date, the optimal ultrasound scanning technique, catheter insertion endpoint, catheter placement location per indication, for the majority of ultrasound-guided continuous peripheral nerve blocks remain unknown. This study will help provide important information related to optimal ultrasound scanning techniques and will help identify ways to improve the success rates, onset times, and analgesic effectiveness of these techniques for real patients undergoing surgical procedures.
详细描述
Primary Aim: To determine if there is an optimal scanning technique for ultrasound-guided perineural catheter insertion that will result in the most accurate tip placement in proximity to the target nerve or plexus.
Secondary Aim: To determine if there is an optimal location for ultrasound-guided perineural catheter insertion along a target nerve or plexus that will result in maximum local anesthetic infusion benefits.
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
- 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
- •At least 18 years of age;
- •Undergoing unilateral, upper (at or distal to the elbow) or lower (hip or distal) extremity orthopedic surgery, with moderate-to-severe postoperative pain expected; and
- •Desiring a continuous perineural catheter for postoperative analgesia.
排除标准
- •Patients who will have difficulty understanding the study protocol or caring for the infusion pump/catheter system; or
- •Patients with any known contraindication to study medications, insulin-dependent diabetes mellitus, neuropathy of any etiology in the affected extremity;
- •Patients with a contraindication to regional blockade (eg, clotting deficiency);
- •Patients with any known acute or chronic hepatic or renal insufficiency or failure;
- •Patients with any additional surgical site outside of the catheter-affected area (eg, iliac crest bone graft in addition to hand surgery);
- •Patients with chronic opioid use (defined as daily use for more than 4 weeks prior to surgery) or active illicit substance abuse;
- •Patient weighing < 40 kg;
- •Pregnancy;
- •Incarceration; or
- •Inability to communicate with the investigators and hospital staff.
结局指标
主要结局
Onset time of sensory anesthesia
时间窗: 30 minutes
The primary outcome will be the onset time of sensory anesthesia in the target nerve distribution following injection of a local anesthetic bolus via the perineural catheter.
次要结局
- Time for placement(30 minutes)
- Postoperative pain(1 day)
研究者
Edward R. Mariano
Staff Physician
VA Palo Alto Health Care System