跳至主要内容
临床试验/NCT01596998
NCT01596998已完成4 期

Comparison of Plasma Concentrations of Levobupivacaine With and Without Epinephrine for Transversus Abdominis Plane Block Under Ultrasound.

Pontificia Universidad Catolica de Chile1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2011年12月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

干预措施: Levobupivacaine without epinephrine (Drug)

Levobupivacaine without epinephrine

Active Comparator

干预措施: Monitoring (Other)

Levobupivacaine without epinephrine

Active Comparator

干预措施: Determining the extent of the block (Other)

Levobupivacaine with epinephrine

Experimental

干预措施: Levobupivacaine with epinephrine (Drug)

Levobupivacaine with epinephrine

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fernando Altermatt

Profesor Asistente, Departamento de Anestesiología

Pontificia Universidad Catolica de Chile

研究点 (1)

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