A Prospective Comparison of Pain and Analgesia in Patients With Continuous Peripheral Nerve Block Catheters Using Continuous Infusion or Scheduled Bolus Infusion
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Post-surgical pain
研究概览
简要总结
The goal of the study is to compare continuous infusions and scheduled bolus infusions for peripheral nerve blocks and their effect on post-surgical pain.
详细描述
Regional anesthetic techniques are an integral part to many anesthetic approaches, providing both intraoperative and postoperative anesthesia and analgesia. Regional anesthesia peripheral nerve blocks have been shown to reduce postoperative pain and improve measures such as opioid requirements and readiness for discharge. By using a catheter technique for continuous peripheral nerve blocks, analgesia can be extended well into post-operative days 2 and 3, further extending these benefits. Historically these catheters have implemented a continuous dosing regimen of local anesthetic, but increasingly there is evidence of improved analgesic outcomes without adverse effects by using a scheduled bolus dosing regimen. Many institutions have implemented this new protocol for catheter dosing. The beneficial effect of scheduled bolus dosing has not been studied in all blocks and all surgical procedures.
The study will consist of three independent arms, each designed to evaluate a different nerve block site: interscalene, adductor canal, and infraclavicular. A total of 60 patients will be enrolled in each arm.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Investigators and participants will be masked to treatment group. Care providers will be necessarily unmasked.
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
- •Adult patients presenting for nerve block catheters for post-operative analgesia
- •ASA physical status I, II, or III.
排除标准
- •Pregnancy
- •Incarceration
- •Pre-operative opioid use >30 mg morphine equivalents per day
- •Inability to communicate with investigators by telephone
- •Pre-existing neuropathy of the operative extremity.
研究组 & 干预措施
Continuous Infusion
Local anesthetic medication (Ropivacaine 0.2%) is provided at a continuous basal rate.
干预措施: Ropivacaine (Drug)
Intermittent Bolus Infusion
Local anesthetic medication (Ropivacaine 0.2%) is provided in scheduled, intermittent boluses.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Post-surgical pain
时间窗: Post-operative day 0, 1, and 2
Pain scores will be collected using a Numeric Rating Scale (NRS) from 0-10, where 0 is the lowest and 10 is the highest pain level.
次要结局
- Opioid consumption(Post-operative day 0, 1, and 2)
- Local anesthetic use(Post-operative day 1 and 2)
- Quality of recovery(Post-operative day 1 and 2)
- Evidence of diaphragmatic paralysis(Post-operative day 1 and 2)
- Patient satisfaction(Post-operative day 1 and 2)
研究者
Jean-Louis Horn
Professor of Anesthesiology
Stanford University