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临床试验/NCT07175298
NCT07175298尚未招募不适用

Efficacy of Serratus Posterior Superior Intercostal Plane Block on Post-operative Pain Management in Patients Undergoing Adult Cardiac Surgery. A Randomized Controlled Trial

Alexandria University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
试验地点
1
主要终点
Total postoperative fentanyl consumption

研究概览

简要总结

Cardiac surgery, particularly procedures involving median sternotomy, is associated with significant postoperative pain. Acute postoperative pain is severe in cardiac patients undergoing sternotomy, and pain intensity is more severe than expected. Poorly controlled pain after surgery can lead to myocardial ischemia and pulmonary infections.Regional anesthesia techniques offer a promising alternative or adjunct to systemic opioids, providing targeted pain relief with fewer systemic side effects. The Serratus Posterior Superior Intercostal Plane Block (SPSIPB) is a novel regional anesthesia technique that involves injecting local anesthetic into the fascial plane between the serratus posterior superior muscle and the intercostal muscles

详细描述

Cardiac surgery, particularly procedures involving median sternotomy, is associated with significant postoperative pain. Acute postoperative pain is severe in cardiac patients undergoing sternotomy, and pain intensity is more severe than expected. Poorly controlled pain after surgery can lead to myocardial ischemia and pulmonary infections.

Effective pain management is crucial for patient recovery, reducing complications, and facilitating early mobilization. Opioids are commonly used for postoperative analgesia but are associated with numerous side effects, including respiratory depression, nausea, vomiting, constipation, and prolonged hospitalization.

Regional anesthesia techniques offer a promising alternative or adjunct to systemic opioids, providing targeted pain relief with fewer systemic side effects. The Serratus Posterior Superior Intercostal Plane Block (SPSIPB) is a novel regional anesthesia technique that involves injecting local anesthetic into the fascial plane between the serratus posterior superior muscle and the intercostal muscles. This block will provide analgesia to the anterolateral and posterior chest wall, covering dermatomes relevant to cardiac surgery.

Preliminary case reports and small studies suggest its efficacy in thoracic and cardiac surgeries, demonstrating effective pain control and reduced opioid consumption. However, a randomized controlled trial is necessary to definitively determine the efficacy and safety of SPSIPB as part of multimodal analgesia in adult cardiac surgery.

Fascial plane blocks in regional anesthesia have gained importance in recent years. It involves injection into a tissue plane to provide analgesia and is an alternative to neuraxial and paravertebral techniques. It is often safer and is associated with less cardiorespiratory instability or complications compared to epidural analgesia.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •aged 18 to 60
  • •both sexes
  • •who are scheduled to have fast-tracking elective on-pump cardiac surgery through a median sternotomy,
  • •American Society of Anesthesiologists Physical status II-III,
  • •Ability to understand and provide informed consent

排除标准

  • •patients who refused to participate in the study,
  • •who had Cognitive impairment or mental disorders,
  • •Ages <18 and >60 years,
  • •BMI <18 and >35,
  • •patients with puncture site infection,
  • •patients who documented allergy to local anesthetic drugs,
  • •patients used to take chronic pain medications, patients who made previous sternotomy or chest surgery
  • •patients with a history of substance abuse.

研究组 & 干预措施

Control Group: PCS fentanyl based

Active Comparator

Control Group: Participants will receive general anaesthesia with a conventional opioid-based technique(fentanyl)

干预措施: conventional opioid-based technique (Procedure)

The Serratus Posterior Superior Intercostal Plane Block group

Experimental

SPSIPB Group: Participants will receive an ultrasound-guided Serratus posterior superior intercostal plane block with 30 ml 0.25% bupivacaine per side pre-incision and general anaesthesia with opioid based fentanyl

干预措施: SPSIPB Group (Procedure)

结局指标

主要结局

Total postoperative fentanyl consumption

时间窗: the first 24 and 48 hours post-extubation.

will be measured as the total amount of fentanyl (in micrograms) consumed via PCA

次要结局

  • Patient satisfaction(at 24 hours post-extubation)
  • Incidence of adverse(28hour postoperative)
  • Time to extubation(post operative 6 hour)
  • Time to first rescue analgesia(48hour post operatively)
  • Postoperative pain intensity(6, 12, 18,24, 36, and 48 hours post-extubation.)
  • Length of stay(post operative 5 days)

研究者

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

Islam Elbardan

LECTURER OF ANESTHESIA AND SURGICALMINTENSIVE CARE

Alexandria University

研究点 (1)

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