Sternotomi İle Kardiyak Cerrahi Planlanan Hastalarda Postoperatif Sternotomi Ağrısının Yönetiminde Erektör Spina Plan Blok (ESPB) Ile Yüzeyel Parasternal İnterkostal Plan Bloğu (SPIPB) ve Serratus Anterior Plan Bloğu (SAPB) Kombinasyonunun Karşılaştırılması
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain Intensity (Visual Analog Scale Score)
研究概览
简要总结
This study aims to compare the effectiveness of two regional anesthesia techniques in managing pain for participants undergoing cardiac surgery via sternotomy. The investigators will evaluate whether the Erector Spinae Plane Block (ESPB) or a combination of the Superficial Parasternal Intercostal Plane Block (SPIPB) and Serratus Anterior Plane Block (SAPB) provides better pain control and recovery outcomes.
详细描述
The investigators aim to compare the effects of the erector spinae plane block (ESPB) versus the combination of superficial parasternal intercostal plane block (SPIPB) and serratus anterior plane block (SAPB) in the management of postoperative sternotomy pain among participants scheduled for cardiac surgery via sternotomy.
Study design and methods: A total of 50 participants (aged 18-80, ASA I-III) scheduled for sternotomy will be randomly assigned to one of two groups:
ESPB Group: Participants receive the Erector Spinae Plane Block. SPIPB + SAPB Group: Participants receive a combination of both blocks. Prior to the induction of general anesthesia, participants are randomized into two groups: the ESPB group and the SPIPB + SAPB group. Nerve blocks are performed in both groups. Visual Analog Scale (VAS) scores at rest and during coughing, intraoperative opioid consumption, postoperative behavioral pain scores, extubation times, and time to the first rescue analgesic requirement are evaluated.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 80 years.
- •Patients classified as American Society of Anesthesiologists (ASA) physical status I, II, or III.
- •Patients scheduled for elective cardiac surgery via median sternotomy.
- •Patients who have provided written informed consent.
排除标准
- •Pregnancy or suspected pregnancy.
- •Body Mass Index (BMI) > 35 kg/m².
- •Known allergy or hypersensitivity to local anesthetics (e.g., bupivacaine).
- •Suspected coagulopathy or bleeding disorders.
- •Infection at the site of the regional block injection.
- •Severe hepatic or renal failure.
- •Severe neurological or psychiatric disorders.
- •Emergency surgical procedures.
- •Re-operation cases (Redo-surgery)
研究组 & 干预措施
Erector Spinae Plane Block Group
Participants in this group will receive a bilateral ultrasound-guided Erector Spinae Plane Block (ESPB) for postoperative analgesia.
干预措施: Erector spinae plane block (ESPB) (Procedure)
SPIPB and SAPB Group
Participants in this group will receive a combination of bilateral ultrasound-guided Superficial Parasternal Intercostal Plane Block (SPIPB) and Serratus Anterior Plane Block (SAPB) for postoperative analgesia.
干预措施: Superficial Parasternal Intercostal Plane Block (SPIPB) (Procedure)
SPIPB and SAPB Group
Participants in this group will receive a combination of bilateral ultrasound-guided Superficial Parasternal Intercostal Plane Block (SPIPB) and Serratus Anterior Plane Block (SAPB) for postoperative analgesia.
干预措施: Serratus Anterior Plane Block (SAPB) (Procedure)
结局指标
主要结局
Pain Intensity (Visual Analog Scale Score)
时间窗: At 0, 1, 2, 4, 8, 12, 16 and 24 hours postoperatively.
Pain levels assessed using the Visual Analog Scale (0 = no pain, 10 = worst imaginable pain).
次要结局
- Total Postoperative Opioid Consumption(From the end of surgery up to 24 hours postoperatively.)
- Behavioral Pain Scale (BPS)(From ICU admission until extubation, assessed up to 24 hours.)
- Extubation Time(From the end of surgery until the date of successful endotracheal tube removal, assessed up to 24 hours.)
- Time to First Rescue Analgesic(From the end of surgery until the first dose of rescue analgesic, assessed up to 24 hours.)
研究者
Onur Alp
Anesthesiology Resident
Uludag University