Efficacy of Ropivacaine Wound Infiltration for Postoperative Pain Management After Minimally Invasive Aortic Valve Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Comparison of cumulative postoperative dose of Piritramid between the two different protocols, using VAS scale to determine level of analgesia.
研究概览
简要总结
The study evaluates the efficacy of local anesthestic application through the catheter in the surgical wound for the postoperative pain relief after minimally invasive aortic valve surgery. The patients will be enrolled in two different groups according to the protocol of the local anesthetic and saline administration:
- group: continous infusion of the local anesthetic plus bolus on demand
- group: continous infusion of saline plus bolus on demand For all patients metamizol every 12 hours plus bolous of piritramid on demand.
详细描述
Patients undergoing minimally invasive aortic valve replacment surgery will be enroled in the study, after giving a signed informed consent.
The study evaluates the efficacy of local anesthestic application through the catheter in the surgical wound for the postoperative pain relief after minimally invasive aortic valve surgery.
Patients will then be randomised in two groups according to the protocol:
- group: continous infusion of the local anesthetic plus bolus on demand
- group: continous infusion of saline plus bolus on demand
All patients will receive Metamizol every 12 hours plus bolus of piritramid on demand.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients after minimally invasive aortic valve surgery
- •Patients agreement with the study
排除标准
- •Age under 18 years
- •Allergy to local anesthetic
研究组 & 干预措施
Ropivacaine continous infusion
Piritramid
干预措施: Piritramid (Drug)
Saline continous
Piritramid
干预措施: Piritramid (Drug)
Saline continous
Piritramid
干预措施: Saline (Drug)
结局指标
主要结局
Comparison of cumulative postoperative dose of Piritramid between the two different protocols, using VAS scale to determine level of analgesia.
时间窗: 48 hours after admission to the intensive care unit (ICU)
Comparison of cumulative postoperative dose of Piritramid between the two protocols
次要结局
- Hospital lenght of stay(Up to 30 days)
- Patients satisfaction with pain relief measured by Likert-type Patient satisfaction scale(72 hours after surgery)
- Visual analogue scale (VAS), frequency of scores higher than 3(48 hours after admission to the ICU)
- Rate of complications related to the local anesthetic(72 hours after surgery)
- Complications related to the catheter in the surgical wound(Up to 30 days)
研究者
Maja Sostaric
asoc. prof.
University Medical Centre Ljubljana