Saphenous Nerve Block for Post-Op Pain Control After Tibial Plateau ORIF
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 50
- 主要终点
- Pain Scores
研究概览
简要总结
Fractures of the tibial plateau, while very painful, typically do not receive nerve blocks. This is because of a concern that the numbness from a nerve block would "mask" the typically painful symptoms of compartment syndrome, a condition that can lead to a permanent loss of function of the injured limb. Our study aims to evaluate the effectiveness of saphenous nerve block for pain management after surgical repair of a tibial plateau fracture. Based on cadaver studies and our clinical experience, we suspect that the saphenous nerve contributes to pain sensations of the tibial plateau and will not mask the pain from a compartment syndrome. In summary, while saphenous nerve block represents a safe option after tibial plateau open reduction internal fixation (ORIF), we aim to evaluate its effectiveness in this patient population.
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
- •Tibial plateau fracture presenting for ORIF
- •Age greater than or equal to 18 years
排除标准
- •Other concomitant life-threatening injuries
- •History of chronic pain prior to tibial plateau ORIF
- •Age <18 years old
- •Pregnancy
- •Any condition impairing patient's ability to consent to participation in study
- •Existing condition contraindicating a nerve block
- •Non-English Speaking
研究组 & 干预措施
Ropivacaine Treatment
After the patient has been consented for a post-operative nerve block, physicians will provide a loading dose of Ropivacaine through the catheter. After one hour, the patient will receive their Ropivacaine infusions as per standard protocol.
干预措施: Saphenous Nerve Block with Ropivacaine Treatment (Procedure)
Saline Control
After the patient has been consented for a post-operative nerve block, physicians will provide a loading dose of Normal Saline through the catheter. After one hour, the patient will receive their Ropivacaine infusions as per standard protocol.
干预措施: Saphenous Nerve Block with Saline Control (Procedure)
结局指标
主要结局
Pain Scores
时间窗: Through hospital stay, an average of 3 days
Pain scores on a scale from 0 to 10 will be collected by the research staff for 1 hour following the post-operative block. Pain scores will also be collected by the nurses throughout the patient's stay.
Opioid requirements
时间窗: Through hospital stay, an average of 3 days
Opioid medications recorded in opioid morphine equivalents will be recorded by the research staff for the first hour following the post-operative nerve block. Opioid medications will be collected by the nurses throughout the patient's stay.
Length of Stay
时间窗: Through hospital stay, an average of 3 days
The patient's length of stay in the hospital will be collected by the research staff following the patient's discharge.
次要结局
未报告次要终点
研究者
Jean-Louis Horn
Principal Investigator
Stanford University