Postoperative Bilateral Serratus Anterior Plane Versus PECS II Block in Intubated Patients Undergoing Elective Coronary Artery Bypass Grafting: A Prospective, Randomized, Placebo-Controlled Trial
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
- Postoperative pain intensity assessed using the Visual Analog Scale (VAS)
研究概览
简要总结
This prospective randomized placebo-controlled trial was designed to evaluate the effects of ultrasound-guided bilateral pectoralis (PECS II) and serratus anterior plane (SAP) blocks on postoperative recovery in adult patients undergoing elective coronary artery bypass grafting (CABG). Patients were randomized to receive bilateral PECS II block, bilateral SAP block, or bilateral sham fascial plane injections in addition to standardized systemic analgesia. The study evaluated postoperative pain intensity using the Visual Analog Scale (VAS), opioid consumption, postoperative nausea and vomiting (PONV), block-related complications, duration of mechanical ventilation, time to first mobilization, and intensive care unit (ICU) length of stay.
详细描述
This prospective, randomized, placebo-controlled trial evaluated the postoperative analgesic efficacy of ultrasound-guided bilateral serratus anterior plane (SAP) block and bilateral PECS II block in adult patients undergoing elective coronary artery bypass grafting (CABG). Participants were randomly assigned to one of three groups: bilateral SAP block, bilateral PECS II block, or bilateral sham fascial plane injections (placebo comparator). All participants received the same standardized postoperative systemic analgesic regimen.
To preserve allocation concealment and blinding, an investigator not involved in patient management prepared identical coded syringes according to the randomization sequence. The physician performing the ultrasound-guided procedures was unaware of syringe contents. All participants underwent bilateral injections at both the PECS II and SAP fascial planes; depending on group allocation, each fascial plane received either 0.25% bupivacaine or 0.9% saline. Postoperative outcome assessment was performed by investigators blinded to treatment allocation.
The primary outcome was postoperative pain intensity measured using the Visual Analog Scale (VAS) at predefined time points after extubation. Secondary outcomes included cumulative opioid consumption during the first 24 postoperative hours, postoperative nausea and vomiting (PONV), and block-related complications. Additional recovery-related outcomes included duration of mechanical ventilation, time to first mobilization, and intensive care unit (ICU) length of stay. These recovery outcomes were analyzed as exploratory endpoints because ICU clinicians were not blinded and important perioperative factors influencing recovery were not systematically collected.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The allocation sequence and coded syringes were prepared by an investigator who was not involved in intervention administration, postoperative care, or outcome assessment. Each participant had two identical-appearing syringes labelled "PECS" and "SAP." The active syringe contained bupivacaine and the other contained 0.9% saline; both syringes contained saline in the sham group. A blinded anesthesiologist performed ultrasound-guided injections in both anatomical regions for every participant and was unaware of syringe contents and allocation. Participants, ICU clinicians responsible for postoperative care, ventilator weaning and extubation, and postoperative outcome assessors were blinded. Only the investigator preparing the syringes had access to the allocation sequence.
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
- 否
入选标准
- •Adults aged 20 years and older ASA physical status II-IV Scheduled for elective coronary artery bypass grafting (CABG) via median sternotomy Extubated in the intensive care unit after surgery Provided written informed consent
排除标准
- •Refusal to participate or inability to provide informed consent Pregnancy Known allergy or contraindication to bupivacaine or other amide local anesthetics Coagulopathy or ongoing anticoagulation precluding regional anesthesia Local infection at the planned injection site Severe hepatic or renal failure Pre-existing chronic opioid use or chronic pain requiring opioid treatment Pre-existing neurological disorders affecting pain assessment Requirement for emergency surgery or concomitant cardiac procedures other than isolated CABG Reoperation for postoperative bleeding before outcome assessment
研究组 & 干预措施
Bilateral SAP Block
Participants undergoing elective coronary artery bypass grafting received an ultrasound-guided bilateral serratus anterior plane (SAP) block using 20 mL of 0.25% bupivacaine on each side. To maintain study blinding, ultrasound-guided placebo injections consisting of 20 mL of 0.9% saline were also administered bilaterally at the PECS II injection sites using identical coded syringes.
干预措施: Bilateral Serratus Anterior Plane Block (Procedure)
Bilateral PECS II Block
Participants undergoing elective coronary artery bypass grafting received an ultrasound-guided bilateral PECS II block using 20 mL of 0.25% bupivacaine on each side. To maintain study blinding, ultrasound-guided placebo injections consisting of 20 mL of 0.9% saline were also administered bilaterally at the serratus anterior plane injection sites using identical coded syringes.
干预措施: Bilateral PECS II Block (Procedure)
Sham Block
Participants undergoing elective coronary artery bypass grafting received ultrasound-guided bilateral placebo injections consisting of 20 mL of 0.9% saline on each side at both the PECS II and serratus anterior plane injection sites using identical coded syringes to maintain study blinding. All participants received the same standardized postoperative systemic analgesic regimen.
干预措施: Sham Fascial Plane Procedure (Procedure)
结局指标
主要结局
Postoperative pain intensity assessed using the Visual Analog Scale (VAS)
时间窗: 4, 8, 12, and 24 hours after extubation
Postoperative pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. Assessments will be performed at 4, 8, 12, and 24 hours after extubation.
次要结局
- Postoperative nausea and vomiting (PONV)(Within 24 hours after surgery)
- Block-related complications(During hospitalization)
- Length of intensive care unit (ICU) stay(From ICU admission to ICU discharge (assessed up to 30 days).)
- Time to first mobilization(From ICU admission to first mobilization (assessed up to 7 days).)
- Duration of mechanical ventilation(From ICU admission to successful extubation (assessed up to 7 days).)
- Total tramadol and pethidine consumption within the first 24 postoperative hours(Within the first 24 postoperative hours)
研究者
Arzu Esen Tekeli
Associate Professor
Yuzuncu Yil University