Effect of Ultrasound-Guided Preemptive Parasternal Intercostal Nerve Block on the Incidence of Chronic Pain After Cardiac Surgery Via Sternotomy: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 174
- 主要终点
- Incidence of chronic post-sternotomy pain at three months
研究概览
简要总结
Chronic post-sternotomy pain is a common but under-recognised complication of cardiac surgery, reported in roughly 11 to 56 percent of patients and capable of persisting for years after the operation. Effective control of pain in the early postoperative period is thought to reduce the central sensitisation that drives the transition from acute to chronic pain.
This single-centre, prospective, randomised, patient- and assessor-blinded controlled trial investigates whether an ultrasound-guided bilateral parasternal intercostal nerve block, performed preemptively after induction of general anaesthesia and before surgical incision, reduces the incidence of chronic pain three months after cardiac surgery performed through a median sternotomy.
A total of 174 adults scheduled for elective cardiac surgery will be randomised in a 1:1 ratio to receive either the block plus the institution's standard multimodal analgesia protocol, or the standard protocol alone. The primary endpoint is the incidence of chronic post-sternotomy pain at three months, assessed with the Turkish version of the Brief Pain Inventory - Short Form. Secondary endpoints cover acute pain scores, opioid consumption, postoperative nausea and vomiting, and complications.
详细描述
Design and setting. The trial will be conducted in the Department of Anesthesiology and Reanimation, University of Health Sciences Istanbul Bakirkoy Dr. Sadi Konuk Training and Research Hospital. Eligible patients will be identified at the preoperative anaesthesia assessment and written informed consent will be obtained.
Randomisation and blinding. Participants will be allocated 1:1 using sequentially numbered, opaque, sealed envelopes prepared in advance. Patients and the investigator performing postoperative assessments will be unaware of group assignment; the anaesthesiologist performing the block cannot be blinded.
Intervention. In the block group, after induction of general anaesthesia and before surgical incision, a bilateral parasternal intercostal nerve block will be performed in the supine position with a high-frequency linear ultrasound probe (6-15 MHz) and a 22 G, 80 mm echogenic block needle.
Anaesthetic and analgesic management, identical in both groups.
Assessments. Pain is scored with the Numeric Rating Scale at rest and on movement at 1, 6, 12 and 24 hours after extubation. Opioid consumption, postoperative nausea and vomiting and any complications are recorded. At three months patients are contacted by telephone and assessed with the Brief Pain Inventory - Short Form, validated in Turkish by Ataman and colleagues.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and the investigator performing postoperative and three-month assessments are blinded to allocation. The anaesthesiologist performing the block cannot be 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
- •Age between 18 and 75 years
- •Scheduled for elective cardiac surgery via median sternotomy
- •Able to understand and use the Numeric Rating Scale for pain
- •Willing to participate and able to provide written informed consent
排除标准
- •Surgery planned by a minimally invasive or thoracoscopic approach
- •Refusal to participate
- •Known allergy to the local anaesthetics or analgesics to be used
- •Chronic opioid use
- •Coagulopathy
- •Infection at the planned block site
- •Pregnancy or lactation
- •Inability to communicate or to score pain reliably
- •Psychiatric or neurological condition preventing reliable completion of the BPI-SF and NRS assessments
研究组 & 干预措施
PINB Group
After induction of general anaesthesia and before surgical incision, participants receive an ultrasound-guided bilateral parasternal intercostal nerve block, in addition to the institutional standard perioperative analgesia protocol.
干预措施: Bupivacaine 0.25% (Drug)
PINB Group
After induction of general anaesthesia and before surgical incision, participants receive an ultrasound-guided bilateral parasternal intercostal nerve block, in addition to the institutional standard perioperative analgesia protocol.
干预措施: Ultrasound-Guided Parasternal Intercostal Nerve Block (Procedure)
Control Group
No regional block is performed. Participants receive only the institutional standard perioperative multimodal analgesia protocol, identical to that given to the block group.
结局指标
主要结局
Incidence of chronic post-sternotomy pain at three months
时间窗: 3 months after surgery
次要结局
未报告次要终点
研究者
İlayda Kalyoncu Karahan
Specialist Doctor (MD), Department of Anesthesiology and Reanimation
Bakirkoy Dr. Sadi Konuk Research and Training Hospital