Prospective Randomized Double-blinded Study of Systemic Pharmacokinetics of Levobupivacaine and Ropivacaine During Continuous Epidural Infusion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 181
- 试验地点
- 2
- 主要终点
- Plasma concentration of the local anesthetics in study
研究概览
简要总结
The aim of the study is the assessment of the systemic absorption of local anesthetics during continuous epidural infusion for postoperative pain control.
详细描述
In literature the systemic toxicity of bupivacaine is widely demonstrated, like the minor toxicity of levobupivacaine and ropivacaine at the same anesthetic potency. The are actually no studies in humans confronting levobupivacaine and ropivacaine under the aspect of efficacy and toxicity.The aim of the study is the assessment of the systemic absorption of local anesthetics during continuous epidural infusion for postoperative pain control.
Primary outcome:
Assessment of the plasmatic equimolar concentrations of levobupivacaine and ropivacaine during continuous epidural infusion
Secondary outcome:
Assessment of the safety level of the local anesthetic (major difference between haematic concentration of the local anesthetic and neuro-cardiotoxic dose).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I or ASA II
- •Scheduled for major surgery
- •written informed consent
排除标准
- •ASA III, IV
- •Emergency surgery
- •Recovery in intensive care unit after surgery
- •habitual opioid consumption
- •cognitive or mental alterations
- •coagulopathy
- •piastrinemia < 100.000/mm3
研究组 & 干预措施
levobupivacaine
干预措施: local anesthetic (Drug)
ropivacaine
干预措施: local anesthetic (Drug)
结局指标
主要结局
Plasma concentration of the local anesthetics in study
时间窗: during 60h after surgery
Assessment of the equivalence of the systemic exposition of levobupivacaine and ropivacaine during 48h continuous epidural infusion with in a range of 15%.Blood samples (8) will be taken for farmacological assessment of local anesthetic plasma concentrations at time (hours) 0,+3h,+6h,+12h,+24h,+48h,+54h,+60h
次要结局
- Assessment of the pharmacological profile of the local anesthetics in study(during 60h after surgery)
- Difference between the to groups (at least 25%) in terms of pain control (1 episode of VAS>4)(Pain control (VAS, VASm, rescue dose) during the 72 h postsurgery)
- Difference at least 20% in presentation of collateral effects between the two groups(Continuous assessment during the 72 h post-surgery)
研究者
Massimo Allegri
MD
Fondazione IRCCS Policlinico San Matteo di Pavia