Comparison of Plasma Concentrations of Levobupivacaine With and Without Epinephrine for Transversus Abdominis Plane Block Under Ultrasound.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Effect of the addition of vasoconstrictor in the plasma concentrations achieved
研究概览
简要总结
The aim of this study is to determine the effect of the addition of vasoconstrictor in the plasma concentrations achieved and the extent of the transversus abdominis plane block in healthy male volunteers.
详细描述
Use of TAP blocks, decreases use of opioids and reduces pain scores during the postoperative period after surgeries involving the anterior abdominal wall. However, the information regarding the sensitive range of the blockade and its duration is still limited. Since that the area of administration is an intermuscular plane, it is possible to infer a large area of absorption. Knowing plasma concentrations is essential to balance the usefulness of this technique with potential systemic toxicity associated with its use.
As an additional effect, clinically, the use of vasoconstrictors may prolong the duration of the blockade significantly, depending on the drug used and site of administration. To date, no studies evaluating the effect of the addition of vasoconstrictor both in the plasma concentrations achieved, and the quality, extent and duration of the TAP block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers
排除标准
- •BMI > 30kg m-2
- •Patients with allergy to study drugs
研究组 & 干预措施
Levobupivacaine without epinephrine
干预措施: Levobupivacaine without epinephrine (Drug)
Levobupivacaine without epinephrine
干预措施: Monitoring (Other)
Levobupivacaine without epinephrine
干预措施: Determining the extent of the block (Other)
Levobupivacaine with epinephrine
干预措施: Levobupivacaine with epinephrine (Drug)
Levobupivacaine with epinephrine
干预措施: Monitoring (Other)
结局指标
主要结局
Effect of the addition of vasoconstrictor in the plasma concentrations achieved
时间窗: Since the beginning of the block up to 90 minutes after
次要结局
- Determine the mapping of sensory block in the abdominal wall after the completion of a U.S. guided TAP Block in healthy volunteers.(Since the beginning of the block up to 4 hours after)
研究者
Fernando Altermatt
Profesor Asistente, Departamento de Anestesiología
Pontificia Universidad Catolica de Chile
