The Double-blind, Randomized Controlled Trial: Comparison of Levobupivacaine and Ropivacaine for Postoperative Analgesia TAP-block After Caesarean Section
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Level of pain
研究概览
简要总结
Randomized, double-blind, controlled trial: a comparison of Levobupivacaine and Ropivacaine for postoperative analgesia using TAP-block
Objectives:
- VAS score during the first 12 hours
- Determine which drug is more effective for postoperative analgesia in the first 12 hours after surgery
- Side effects
详细描述
For TAP-block was used Hirokain® (Levobupivacaine) . Injectable solution 7.5 mg / ml; ampoule polypropylene 10 ml, a pack of cardboard 10; No. ЛП-003106, 2015-07-21 to 2020-07-21 from EbbVi Ltd. (Russia); manufacturer: Kurida AS (Norway); Packer: AbbVi S.r.l. (Italy), or Ropivacaine Kabi (Ropivacaine Kabi) (Ropivacaine) Solution for injection 7.5 mg / ml; ampoule polypropylene 1 10 ml, a pack of cardboard 5; EAN code: 4607085481524; No. ЛП-002897, 2015-03-04 to 2020-03-04 from Fresenius Kabi Deutschland GmbH (Germany); manufacturer: Fresenius Kabi Norge (Norway).
Both preparations were diluted to a volume of 50 ml, at a concentration of 3 mg / ml.
It was performed by TAP-block in-plain with a 22G needle Quincke, on both sides, and 25 ml on each side was injected.
The pain syndrome was assessed with admission, and every 2 hours during the first 12 hours after the operation, using a digital scale on the VAS.
All patients received NSAIDs (Ketorol 3 mg IV every 6 hours from admission)
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
- Double (Participant, Investigator)
盲法说明
Women after the operation do not know what drug they injected with TAP-block The researcher does not know what type of drug is injected
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Cesarean section pfannenstiel incision under spinal anesthesia
- •Spinal anesthesia with Bupivacaine heavy 0,5%
- •Without any adjuvants
排除标准
- •Any other anesthesia exept spinal
- •Any other surgical incision
研究组 & 干预措施
Ropivacaine
TAP-block with Ropivacaine Solution
干预措施: Ropivacaine Solution (Drug)
Levobupivacaine
TAP-block with Levobupivacaine Solution
干预措施: Levobupivacaine Solution (Drug)
结局指标
主要结局
Level of pain
时间窗: 12 hours
Measurement of pain on a VAS scale (from 0 to 10 points)
次要结局
- The need for additional analgesics (Paracetamol, Tramadol)(12 hours)
研究者
Alexandr Ronenson
Head of department of Anaesthesiology and Intensive Care Unit
Tver Regional Perinatal Center