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临床试验/NCT05774249
NCT05774249已完成不适用

The Value of Adding Pecto-intercostal Fascial Plane Block on the Postoperative Analgesia and Recovery Profile After Off-Pump Coronary Artery Bypass Surgery

Ain Shams University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
visual analogue score

研究概览

简要总结

Moderate to severe postoperative pain is usually encountered after cardiac surgery.Improper postoperative pain control could have multiple hemodynamic hazards in addition to prolonged postoperative ventilatory support and intensive care unit stay .The safety and efficacy of ultrasound guided chest wall plane blocks has been described for postoperative analgesia after cardiac surgeries.

Study objective: to investigate the effect of adding of pecto-intercostal fascial plane block on the postoperative pain control, perioperative analgesic consumptions and the time for ventilation weaning and intensive care unit discharge in patients who will undergo off-pump Coronary artery bypass surgeries.

Methods: This study patients will be randomly assigned to 2 Groups to receive preoperative ultrasound-guided pecto-intercostal fascial plane block with either 20 mL of 0.25% bupivacaine with adrenaline 1:400,000 or saline bilaterally.

详细描述

After preoperative patients' anesthesia assessment; the study patients (20 in each group) will receive general anesthesia under invasive monitoring of hemodynamics, and oxygen saturation. After anesthesia induction; cannulation of jugular vein and insertion of transoesophageal echocardiography and temperature probe will be done. In block group : while Patients in supine decubitus position,parasternal area will be scanned using high frequency ultrasound linear probe .After identification of ribs with intercostal spaces in between ;the fourth intercostal space will be approached via 10 cm block needle targeting the plane between pectoralis major and external intercostal muscle under ultrasound guidance after which 20 mL of 0.25% bupivacaine with adrenaline 1:400,000 will be administered in increments bilaterally. In control group:Sham Block will be done using 20 mL of normal saline 0.9% bilaterally .

Anesthesia will be maintained with sevoflurane inhalational anesthesia and incremental cisatracurium and fentanyl for intraoperative muscle relaxation and analgesia respectively. Intraoperative anticoagulation will be carried out before revascularization using intravenous heparin titrated according to activated clotting time ,which will be reversed after end of surgery using protamine sulfate.

At the end of surgery patients will be sent to post cardiac surgery intensive care unit . Postoperative analgesia in the form of intravenous paracetamol one gram will be administered on intensive care unit admission then fentanyl based patient controlled analgesia will be started . IV tramadol 1mg/kg as second rescue analgesia will be given if visual analogue scores are still ≥ 4.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • NYHA ( New york heart association ) class I- III

排除标准

  • Parents' refusal to study participation.
  • Patients with poor coronary vessels targets.
  • Patients with poor cardiac systolic function or preoperative hemodynamic unstability
  • Redo coronary artery bypass surgery
  • Intraoperative complication need conversion to on pump surgery
  • Postoperative exploration for bleeding or poor coronary revascularization
  • Advanced COPD(chronic obstructive pulmonary disease) patients.
  • Myopathies and myasthenic patients
  • Allergy to study medications

结局指标

主要结局

visual analogue score

时间窗: 24 th hour after extubation

0 (no pain) and 100 (worst possible pain)

次要结局

  • postoperative complication(72 hours after surgery)
  • Total postoperative opioid consumption(24 hour after operation)
  • Time to patient extubation(at the end of surgery)
  • time for ICU discharge(72 hours after surgery)
  • Total intraoperative opioid consumption(during the operation)
  • Number of patients need postoperative rescue tramadol(24 hours after extubation)

研究者

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

RAMY AHMED

Assistant Professor of Anesthesia

Ain Shams University

研究点 (2)

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