Ultrasound-Guided Serratus Posterior Superior Plane and Transversus Thoracic Plane Blocks for Postoperative Analgesia After Coronary Artery Bypass Grafting: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 88
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to learn if combining two ultrasound-guided nerve blocks - one for the front of the chest and one for the side of the chest - works better than standard pain medications alone to treat pain after coronary artery bypass grafting (CABG) surgery. It will also learn about the safety of these nerve blocks. The main questions it aims to answer are:
Does the combined nerve block approach lower the amount of opioid pain medication needed in the first 24 hours after surgery? Does the combined nerve block approach lower pain scores at rest and with movement compared to standard care? What medical problems do participants have when receiving the nerve blocks (such as bleeding, infection, or effects from the local anesthetic)? Researchers will compare the combined nerve block group to a standard care group (no nerve blocks) to see if the blocks improve pain control and recovery after heart surgery.
Participants will:
Be randomly assigned to one of two groups: (1) combined nerve blocks plus standard pain medications, or (2) standard pain medications alone Receive the nerve blocks during surgery while under general anesthesia (if assigned to the block group) Have their pain levels checked regularly using a 0-10 scale for the first 48 hours after surgery Have their breathing, walking time, and opioid medication use monitored during their hospital stay Complete a satisfaction survey about their pain management before leaving the hospital Stay in the hospital for their routine recovery period (typically 5-7 days) with no extra visits required
详细描述
This is a single-center, patient- and outcome-assessor-blinded, randomized controlled trial conducted at Ain Shams University Hospitals, Cairo, Egypt. Adults aged 18-75 years scheduled for elective isolated CABG via median sternotomy will be enrolled.
Eligible participants will be randomized 1:1 to either:
Intervention group: Bilateral transversus thoracic plane (TTP) block + bilateral serratus posterior superior (SPSP) block with 0.25% bupivacaine (15 mL per side per block, total 60 mL = 150 mg), performed after induction of general anesthesia and before surgical incision, plus standardized multimodal systemic analgesia.
Control group: Standardized multimodal systemic analgesia alone (no nerve blocks).
Both groups will receive identical standardized anesthesia (fentanyl, propofol, atracurium, sevoflurane), intraoperative hemodynamic management, and postoperative analgesia (IV paracetamol 1 g q6h scheduled, IV ketorolac 30 mg q8h for 24h then 15 mg q8h, rescue IV morphine via protocolized algorithm and patient-controlled analgesia).
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
This is a patient- and outcome-assessor-blinded trial. Participants are blinded because all receive identically labelled "study injection" syringes and are under general anesthesia during block performance. Outcome assessors (ICU nurses, data collectors, and statisticians) are blinded to group allocation and access only coded data.
The block-performing anesthesiologist is the only unblinded individual. This person is considered both a care provider and an investigator and is therefore excluded from masking for those roles. The block performer is not involved in postoperative care, outcome assessment, or data analysis, per CONSORT 2010 guidelines for interventional trials where complete blinding of the performer is not feasible. All other anesthesiologists, surgeons, and ICU staff are blinded.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-65 years.
- •Scheduled for elective, isolated CABG via median sternotomy.
- •American Society of Anesthesiologists (ASA) physical status II-III.
- •Ability to understand the study procedures, provide written informed consent, and reliably report pain scores using the NRS.
排除标准
- •Emergency surgery or pre-operative hemodynamics instability.
- •Known allergies or hypersensitivity to local anesthetics, paracetamol, morphine, or any study medication.
- •Coagulopathy, uncontrolled bleeding risk, or therapeutic anticoagulation that cannot be safely withheld per institutional guidelines (INR > 1.5; platelets < 100 × 10⁹/L at time of block).
- •Local infection or cellulitis at any planned injection site on the anterior or lateral chest wall.
- •Pre-existing chronic pain syndrome requiring daily opioid analgesia or known opioid dependence.
- •Significant cognitive impairment, severe psychiatric disorder, or inability to reliably use pain scales.
- •History of prior thoracic surgery or major chest wall deformity distorting anatomy or limiting the ultrasound window.
- •Pregnancy or breastfeeding.
- •Any other condition judged by the investigator to represent unacceptable risk or preclude study participation.
- •Patient refusal or withdrawal of consent.
研究组 & 干预措施
Combined SPSP + TTP Block
Participants receive bilateral ultrasound-guided serratus posterior superior (SPSP) plane block and bilateral transversus thoracic plane (TTP) block.
干预措施: Transversus Thoracic Plane Block (Procedure)
Combined SPSP + TTP Block
Participants receive bilateral ultrasound-guided serratus posterior superior (SPSP) plane block and bilateral transversus thoracic plane (TTP) block.
干预措施: Transversus Thoracic Plane (TTP) Block (Procedure)
Combined SPSP + TTP Block
Participants receive bilateral ultrasound-guided serratus posterior superior (SPSP) plane block and bilateral transversus thoracic plane (TTP) block.
干预措施: Conventional Systemic Analgesia (Drug)
Conventional Analgesia Group
Participants receive standardized multimodal systemic analgesia alone without any regional anesthesia blocks.
干预措施: Conventional Systemic Analgesia (Drug)
Combined SPSP + TTP Block
Participants receive bilateral ultrasound-guided serratus posterior superior (SPSP) plane block and bilateral transversus thoracic plane (TTP) block.
干预措施: Bupivacaine 0.25% (Drug)
研究者
Mohamed Alaaeldin Alhadidy
Principal Investigator
Ain Shams University