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临床试验/NCT06453681
NCT06453681已完成4 期

Dexmedetomidine as an Adjuvant to Bupivacaine in Bilateral Pectoral Nerve Blocks for Postoperative Pain Control After Cardiac Surgeries: A Randomized Controlled Trial

Kasr El Aini Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
The duration of analgesia

研究概览

简要总结

the study aims to test the quality of analgesia provided by dexmedetomidine as an adjuvant to bupivacaine bilateral PECs block in patients scheduled for cardiothoracic surgeries with median sternotomy incision.

详细描述

Background: Good postoperative analgesia in cardiac surgical patients helps in early recovery and ambulation. An alternative to parenteral, paravertebral, and thoracic epidural analgesia can be pectoralis nerve (Pecs) block, which is a novel, less invasive regional analgesic technique.

The study aims to test the quality of analgesia provided by dexmedetomidine as an adjuvant to bupivacaine bilateral PECs block in patients scheduled for cardiothoracic surgeries with median sternotomy incision.

sixty adult patients between the age groups of 25 and 65 years undergoing coronary artery bypass grafting or valve surgeries through midline sternotomy under general anesthesia were enrolled in the study. Patients were randomly allocated into two groups with 30 ineach group. Group 1 patients will receive bilateral Pecs block, whereas Group 2 patients will receive bilateral Pecs block with dexameditomedine postoperatively. Patients will be extubated once they fulfilled extubation criteria. Ventilator duration will be recorded. Patients will be interrogated for pain by visual analog scale (VAS) scoring at rest and cough. Inspiratory flow rate will be assessed using incentive spirometry.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All adult patients between the age groups of 25 and 65 years undergoing either coronary artery bypass grafting (CABG) or valve surgeries through midline sternotomy under general anesthesia

排除标准

  • Skin erosions, hematomas or infection at the injection site.
  • coagulopathy, ACT more than 150 seconds
  • History of hypersensitivity to bupivacaine or Dexametomedine.
  • The Patients who are unable to use the pain score.
  • patients who will need prolonged post-operative ventilation or inotropic support.

研究组 & 干预措施

bupivacain

Active Comparator

patients receive bilateral Pecs block with bupivacin 0.25%,

干预措施: bilateral PECS (Other)

dexameditomedine bupivacain

Active Comparator

patients received bilateral Pecs block with bupivacin 0.25% plus dexmedetomidine 0.5 μg/Kg as adjuvant.

干预措施: bilateral PECS (Other)

dexameditomedine bupivacain

Active Comparator

patients received bilateral Pecs block with bupivacin 0.25% plus dexmedetomidine 0.5 μg/Kg as adjuvant.

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

The duration of analgesia

时间窗: up to 24 hour

from block start time (time of LA injection) to block end time at which VAS score 4 or more)

次要结局

未报告次要终点

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mohamed Mohamed Elhaddad

Assisstent professor

Kasr El Aini Hospital

研究点 (2)

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