The Effectiveness of the Serratus Posterior Superior Intercostal Plane Block on Postoperative Analgesia and Recovery in Open-heart Surgery: A Prospective, Double-blind, Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- opioid consumption
研究概览
简要总结
Postoperative pain following open-heart surgery is a significant challenge that may negatively affect recovery and overall clinical outcomes. Due to the risks and contraindications associated with neuraxial techniques, the use of fascial plane blocks has increased in recent years. In patients undergoing cardiac surgery, the location and intensity of postoperative pain may vary daily. However, during the first 24 hours, pain is typically most pronounced at the median sternotomy incision site and at the insertion sites of chest, mediastinal, and pleural drains.
Current postoperative analgesia practices in open-heart surgery commonly include multimodal regimens using simple analgesics such as paracetamol and nonsteroidal anti-inflammatory drugs, combined with a regional anesthesia technique such as the parasternal block. The Serratus Posterior Superior Intercostal Plane Block (SPSIPB) is an interfascial plane block that involves the injection of local anesthetic between the serratus posterior superior and intercostal muscles, providing wide dermatomal coverage from the upper cervical to lower thoracic regions. Although the technique has been used successfully in individual clinical cases, no randomized controlled studies have been conducted to evaluate its efficacy in open-heart surgery.
This study aims to compare the postoperative analgesic effectiveness of the SPSIPB with a combination of parasternal block and local anesthetic infiltration at drain insertion sites in patients undergoing open-heart surgery.
详细描述
Postoperative pain following open-heart surgery is a significant challenge that may negatively affect recovery and overall clinical outcomes. Due to the risks and contraindications associated with neuraxial techniques, the use of fascial plane blocks has increased in recent years. In patients undergoing cardiac surgery, the location and intensity of postoperative pain may vary daily. However, during the first 24 hours, pain is typically most pronounced at the median sternotomy incision site and at the insertion sites of chest, mediastinal, and pleural drains.
Current postoperative analgesia practices in open-heart surgery commonly include multimodal regimens using simple analgesics such as paracetamol and nonsteroidal anti-inflammatory drugs, combined with a regional anesthesia technique such as the parasternal block. The Serratus Posterior Superior Intercostal Plane Block (SPSIPB) is an interfascial plane block that involves the injection of local anesthetic between the serratus posterior superior and intercostal muscles, providing wide dermatomal coverage from the upper cervical to lower thoracic regions. Although the technique has been used successfully in individual clinical cases, no randomized controlled studies have been conducted to evaluate its efficacy in open-heart surgery.
This study aims to compare the postoperative analgesic effectiveness of the SPSIPB with a combination of parasternal block and local anesthetic infiltration at drain insertion sites in patients undergoing open-heart surgery.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-85 years with ASA physical status II-III undergoing elective open-heart surgery.
排除标准
- •Patients who do not consent to participate in the study
- •Patients with coagulopathy
- •History of allergy or toxicity to local anesthetics
- •Patients with hepatic or renal failure
- •Patients with uncontrolled diabetes mellitus
- •Patients with uncontrolled hypertension
- •Mentally disabled patients
- •Patients receiving chronic pain therapy (opioid use)
- •Use of antidepressant medication
- •Presence of neuropathic pain
- •Presence of infection at the injection site
- •Pregnant, suspected pregnant, or breastfeeding women
研究组 & 干预措施
Group Control
Parasternal block and local infiltration at the drain insertion site.
干预措施: Parasternal blocks (Other)
Group Control
Parasternal block and local infiltration at the drain insertion site.
干预措施: Local Infiltration (Other)
Group SPSIPB
It will be administered bilaterally before the induction of general anesthesia.
干预措施: SPSIPB blcok (Other)
结局指标
主要结局
opioid consumption
时间窗: 0, 2, 4, 8, 16 and 24 hours
Fentanyl will be prepared at a concentration of 10 µg/mL, and patient-controlled analgesia (PCA) will be administered without a basal infusion, using a lock-out interval of 20 minutes and a bolus dose of 20 µg.
次要结局
- Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable")(0, 2, 4, 8, 16 and 24 hours)
- Global recovery scoring system (patient satisfaction scale)- QoR-15(The quality of recovery will be evaluated out of a total of 150 points according to the QoR-15 test to be applied at the portoperative 24th hour.)
研究者
eralp çevikkalp
assoc prof
Bursa City Hospital