Comparison of Postoperative Analgesic Effectiveness of Erector Spinae Plane Block and Combined With Superficial Parasternal Intercostal Plane Block Within the Enhanced Recovery After Cardiac Surgery (ERACS) Program: A Prospective, Randomized, Double-Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- VAS (resting)
研究概览
简要总结
This prospective, randomized, double-blind, parallel-group clinical trial within the Enhanced Recovery After Cardiac Surgery (ERACS) program compares postoperative analgesic effectiveness of bilateral erector spinae plane (ESP) block versus ESP combined with superficial parasternal intercostal plane (SPIP) block in adult patients undergoing elective cardiac surgery via median sternotomy.
详细描述
Rationale: Effective multimodal, opioid-sparing analgesia is crucial in cardiac surgery to enhance recovery and reduce pulmonary and cognitive complications. Neuraxial techniques (e.g., epidural) carry increased hematoma risk under anticoagulation; hence, fascial plane blocks like ESP and SPIP are safer alternatives.
Methodology: Randomized (ResearchRandomizer.org), 1:1 allocation, opaque sealed envelopes. ESP and SPIP performed under ultrasound guidance at standardized doses and locations.
Blinding: Patients and postoperative evaluators are blinded; block-performing anesthesiologist unblinded but uninvolved in assessment.
Follow-up: 0-72 hours after extubation with predefined time points for VAS, RASS, and Nu-DESC evaluations.
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)
盲法说明
The study will be double-blind, meaning neither the researchers nor the participants will know which treatment group they belong to, ensuring unbiased outcome assessment.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective cardiac surgery via median sternotomy under the ERACS protocol
- •Age between 18 and 80 years
- •ASA physical status II-III
- •Body Mass Index (BMI) between 18 and 35 kg/m²
- •No cognitive impairment (able to cooperate and follow commands)
- •No history of chronic pain or regular analgesic use
- •Provided written informed consent after detailed explanation of the study
排除标准
- •Age < 18 years or > 80 years
- •ASA physical status ≥ IV
- •Emergency surgery
- •Pregnant or breastfeeding women
- •Redo coronary artery bypass surgery
- •Pre-existing cognitive disorder or psychiatric illness affecting pain or delirium evaluation
- •Infection or skin lesion at the injection site
- •Known allergy or hypersensitivity to local anesthetics (bupivacaine or amide type)
- •Chronic pain or opioid use prior to surgery
- •Unwillingness to participate or withdrawal of consent at any stage
结局指标
主要结局
VAS (resting)
时间窗: Up to 72 hours post-extubation
Average of VAS scores at 0, 1, 6, 12, 24, 48, and 72 hours after extubation (t=0). Lower scores indicate better analgesia. Pain was assessed using the 0-10 Visual Analog Scale (VAS). Pain severity was classified as follows: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain. Rescue analgesia was administered when VAS score was \> 4.
VAS (resting)
时间窗: Up to 72 hours post-extubation
Average of VAS scores at 0, 1, 6, 12, 24, 48, and 72 hours after extubation (t=0). Lower scores indicate better analgesia. Pain was assessed using the 0-10 Visual Analog Scale (VAS). Pain severity was classified as follows: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain. Rescue analgesia was administered when VAS score was \> 4.
次要结局
- VAS (movement)(0-72 hours)
- Total rescue tramadol use (mg)(0-72 hours)
- Time to first rescue analgesic (min)(0-72 hours)
- Delirium incidence (Nu-DESC ≥ 2)(12, 24, 48, 72 hours)
- RASS score profile(0, 12, 24, 48, 72 hours)
- VAS (movement)(0-72 hours)
- Total rescue tramadol use (mg)(0-72 hours)
- Time to first rescue analgesic (min)(0-72 hours)
- Delirium incidence (Nu-DESC ≥ 2)(12, 24, 48, 72 hours)
- RASS score profile(0, 12, 24, 48, 72 hours)
研究者
FATMA CANDAN YEREBAKAN
Principal Investigator
Ankara University