Pharmacokinetics of Levobupivacaine and Epinephrine for Transversus Abdominis Plane (TAP) Block for Cesarean Section Postoperative Analgesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Levobupivacaine free plasma levels
研究概览
简要总结
Transversus abdominis plane (TAP) block provides effective analgesia and is now a standard of care for analgesia after cesarean section. There is no information on levobupivacaine pharmacokinetics post TAP after pregnancy.
Objective: Generate a pharmacokinetic levobupivacaine model and its effect on the electrocardiogram (ECG).
Method: The investigators will study 12 healthy term pregnant patients, scheduled for elective cesarean section under spinal anesthesia. A bilateral TAP block is performed with 20 ml 0.25% levobupivacaine with epinephrine 5 ug/ml. Sensory block will be assessed at 1-2-6 and 12 hours post puncture. 2 ml of venous blood will be obtained at 2-5-10-30-45-60-90 and 180 minutes. With a Holter machine we will study the effect of levobupivacaine plasma levels and the QTc changes.
Expected results: 1) Plasma levobupivacaine levels; 2) Changes in QTc .
详细描述
Introduction.
Post cesarean section pain control is a challenging task since it is one of the ten most painful surgeries. Multiple strategies have been proposed for pain control, including neuraxial analgesia, systemic opioids, non-opioid drugs and peripheral nerve blocks, among others.
Transversus abdominal plane (TAP) blocks have been proven to provide effective analgesia when used as part of a multimodal analgesic regimen after abdominal surgery and is becoming a popular technique for post cesarean section analgesia, although recent reports of local anesthesia toxicity have raised concerns about its safety in this population. Currently there is no information on the pharmacokinetics of levobupivacaine of the technique in pregnant patients to guide dosing in a safer way.
Our objective is to generate a pharmacokinetic model to characterize the plasmatic levels of levobupivacaine co-administered with epinephrine and its effect on the ECG, for TAP block in post cesarean section patients.
Methods.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Term pregnant patients
- •American Society of Anesthesiologists physical status I or II, scheduled for elective cesarean section.
排除标准
- •Allergy/sensitivity to the local anaesthetic
- •Significant renal or liver dysfunction.
研究组 & 干预措施
Pharmacokinetics
A bilateral TAP block will be performed with 20 ml levobupivacaine 0,25% and epinephrine (5ug/ml). After the blockade, venous blood samples will be taken on predefined times.
干预措施: Levobupivacaine (Drug)
Pharmacokinetics
A bilateral TAP block will be performed with 20 ml levobupivacaine 0,25% and epinephrine (5ug/ml). After the blockade, venous blood samples will be taken on predefined times.
干预措施: Spinal anesthesia (Procedure)
Pharmacokinetics
A bilateral TAP block will be performed with 20 ml levobupivacaine 0,25% and epinephrine (5ug/ml). After the blockade, venous blood samples will be taken on predefined times.
干预措施: Peripheral vein canulation (Procedure)
Pharmacokinetics
A bilateral TAP block will be performed with 20 ml levobupivacaine 0,25% and epinephrine (5ug/ml). After the blockade, venous blood samples will be taken on predefined times.
干预措施: Ultrasonography (Procedure)
Pharmacokinetics
A bilateral TAP block will be performed with 20 ml levobupivacaine 0,25% and epinephrine (5ug/ml). After the blockade, venous blood samples will be taken on predefined times.
干预措施: Holter (Device)
结局指标
主要结局
Levobupivacaine free plasma levels
时间窗: 180 minutes
Plasma levobupivacaine will be assessed at defined timepoints after TAP block
次要结局
- EKG(12 hours)
研究者
Héctor Lacassie
M.D.
Pontificia Universidad Catolica de Chile