A Prospective, Randomized Controlled Trial Comparing Serratus Anterior Plane Block (SAP), Pectoral Nerve Blocks (PECS I-II), and Standard Systemic Analgesia on Mechanical Ventilation Duration and Postoperative Recovery After Coronary Artery Bypass Grafting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 243
- 试验地点
- 1
- 主要终点
- Duration of Mechanical Ventilation
研究概览
简要总结
The effects of anterior chest wall blocks (PECS and SAP will be used in this study) performed for postoperative analgesia on pain scores (to be checked with visual analogue scale (VAS), opioid consumption, length of hospital stay, mobilization time, side effects and complications in the postoperative period will be examined.
详细描述
Patients meeting the inclusion criteria and providing written informed consent were randomly assigned to one of three parallel study groups using a computer-generated randomization sequence prepared by an independent investigator.
Participants were allocated in a 1:1:1 ratio to:
Group S (Serratus Anterior Plane Block - SAP):
Following coronary artery bypass grafting (CABG), patients were transferred to the cardiovascular intensive care unit (ICU). Within the first 30 minutes after ICU admission, an ultrasound-guided serratus anterior plane (SAP) block was performed using an 8-cm peripheral block needle. After appropriate aseptic preparation of the anterior chest wall, 30 mL of 0.25% bupivacaine was injected into the fascial plane either superficial or deep to the serratus anterior muscle at the level of the fourth rib. All patients additionally received standardized multimodal systemic analgesia.
Group P (Pectoral Nerve Block - PECS I-II):
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)
盲法说明
Participants and outcome assessors were blinded to group allocation. The anesthesiologist performing the regional block was not blinded. ICU clinicians responsible for extubation decisions were unaware of treatment allocation.
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Agreeing to participate in the study,
- •20-65 years old
- •ASA I-II-III
- •Open heart surgery
排除标准
- •Refusal to participate in the study
- •20 years old, over 65 years old
- •Pregnancy
- •Presence of bleeding diathesis
- •Liver or kidney failure
- •Receiving effective treatment on immunity
- •Immune suppressed
- •Those with BMI ≥30
研究组 & 干预措施
Group S - Serratus Anterior Plane Block
Patients received an ultrasound-guided serratus anterior plane (SAP) block with 30 mL of 0.25% bupivacaine within the first 30 minutes after ICU admission in addition to standardized systemic analgesia.
干预措施: Serratus anterior plane block (Procedure)
Group P - Pectoral Nerve Block (PECS I-II)
Patients received ultrasound-guided PECS I-II block with a total of 30 mL of 0.25% bupivacaine within the first 30 minutes after ICU admission in addition to standardized systemic analgesia.
干预措施: PECS I-II (Procedure)
Group C - Standard Systemic Analgesia
Patients received standardized multimodal systemic analgesia without any regional block. Postoperative analgesia consisted of scheduled intravenous paracetamol and rescue opioid administration as needed.
干预措施: Standard Systemic Analgesia (Other)
结局指标
主要结局
Duration of Mechanical Ventilation
时间窗: Within the first 24 postoperative hours
Time (in hours) from ICU admission to successful extubation.
次要结局
- Length of Intensive Care Unit (ICU) Stay(Assessed once at the time of ICU discharge, measured as total hours from ICU admission to ICU discharge (expected within 30 postoperative days).)
- Postoperative Pain Intensity at Rest (VAS)(Assessed at 0, 4, 8, 12, and 24 hours after extubation within the first 24 hours post-extubation.)
- Total Rescue Opioid Consumption (Morphine Equivalents)(Within the first 24 hours after extubation)
- Time to First Mobilization(Assessed once when first active sitting at bedside is achieved, within 48 hours after ICU admission.)
- Postoperative Nausea and Vomiting (PONV)(Assessed at 0-24, 24-48, and 48-72 hours after extubation during postoperative ICU and ward follow-up.)
- Length of Hospital Stay(Assessed once at hospital discharge, measured as total days from date of surgery to hospital discharge (expected within 30 postoperative days).)
研究者
Arzu Esen Tekeli
Associate Professor
Yuzuncu Yil University