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临床试验/NCT03230227
NCT03230227已完成不适用

Presternal Local Analgesia for Postoperative Pain Relief After Open Heart Surgery

Assiut University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
postoperative pain

研究概览

简要总结

Effective pain relief after cardiac surgery has assumed importance with the introduction of fast track discharge protocols that requires early weaning from mechanical ventilation. Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of atelectasis, and prolongs recovery. Infiltration of local anesthetics near the surgical wound has shown to improve early postoperative pain in various surgical procedures.

Magnesium is the fourth most plentiful cation in our body. It has antinociceptive effects in animal and human models of pain.

详细描述

Effective pain relief after cardiac surgery has assumed importance with the introduction of fast track discharge protocols that requires early weaning from mechanical ventilation. Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of atelectasis, and prolongs recovery.

A major cause of pain after cardiac surgery is the median sternotomy particularly on the first two postoperative days.

The most often used analgesics in these patients are parenteral opioids which can lead to undesirable side-effects as sedation, respiratory depression, nausea, and vomiting.

Infiltration of local anesthetics near the surgical wound has shown to improve early postoperative pain in various surgical procedures.

Magnesium is the fourth most plentiful cation in our body. It has antinociceptive effects in animal and human models of pain.

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)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-60 years old
  • American Society of Anesthesiologists physical status II and III
  • Patients scheduled for open heart surgery with sternotomy

排除标准

  • - Emergency surgery
  • Clinically significant kidney or liver disease
  • Patients allergic to local anesthetic
  • Patients with prolonged CPB time (>120 min)
  • Patients required intra-aortic balloon pump

研究组 & 干预措施

Bupivacaine magnesium

Active Comparator

( bupivacain 0.125% magnesium sulfate 5%) infusion in the presternum , for 48 hours

干预措施: Bupivacaine magnesium (Drug)

bupivacain only

Active Comparator

bupivacaine 0.125% infusion in the presternum , for 48 hours

干预措施: Bupivacaine only (Drug)

结局指标

主要结局

postoperative pain

时间窗: 2 days

assessing VAS scale

次要结局

  • hemodynamics(24 hours)

研究者

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

Emad Zarief , MD

lecturer of anesthesia and ICU

Assiut University

研究点 (1)

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