Minimum Effective Concentration of Bupivacaine for Motor-Sparing Femoral Nerve Block
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Minimum Bupivacaine Analgesic concentration preserving quadriceps strength analgesia
研究概览
简要总结
Femoral nerve blocks are commonly used to provide pain control for total knee replacement, anterior cruciate ligament (ACL) reconstruction. Commonly employed local anesthetic concentrations result in motor block of the quadriceps and constitute an inherent risk factor for patient fall.
The aim of this study is to determine the minimum effective concentration of bupivacaine in 90 % of patients (MEC90) required for a motor-sparing, successful sensory block of the femoral nerve.
详细描述
With the approval of Ethics Committee of the University of Chile Clinical Hospital, approximately 60 patients undergoing ACL repair or TKR will be recruited. All blocks will be conducted preoperatively in an induction room.Dose assignation will be done using an up-and-down sequential method, where the dose of each subsequent patient depends on the response of the previous patient, called the Biased Coin Design.
The assignment of each subsequent concentration will be based on the response of the previous patient.As soon as we recruit 45 patients with random dose assignment, we will terminate the enrollment procedure.
The injectate will be prepared and administered by a research assistant using syringes connected to the block needle. The operator and the patient will be blinded to the concentration injected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years
- •American Society of Anesthesiologists classification 1-3
- •Body mass index between 20 and 35
排除标准
- •Adults who are unable to give their own consent
- •Pre-existing neuropathy (assessed by history and physical examination)
- •Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets≤ 100, International Normalized Ratio≥ 1.4 or partial prothrombin time ≥ 50)
- •Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
- •Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
- •Allergy to LA
- •Pregnancy
- •Prior surgery in the inguinal region
- •Chronic pain syndromes requiring opioid intake at home
研究组 & 干预措施
same dose
patient is exposed to the same previously successful dose
干预措施: Same Bupivacaine Concentration (Drug)
lower dose
patient is exposed to a lower concentration dose
干预措施: Lower Bupivacaine Concentration (Drug)
结局指标
主要结局
Minimum Bupivacaine Analgesic concentration preserving quadriceps strength analgesia
时间窗: 5 months
次要结局
未报告次要终点
研究者
Julian Aliste
MD, Attending Anesthesiologist, Clinical Instructor
University of Chile