Ultrasound-guided Erector Spinae Plane (ESP) Block Attenuates Surgery-related Stress Response in Cardiac Surgery Patients Undergoing Enhanced Recovery After Surgery (ERAS) Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Basal measurements- after anesthesia induction
研究概览
简要总结
Surgery-induced pain reveals its own metabolic and inflammatory responses, resulting in a further increase in noxious pathways that are already occurring. Even though it is difficult to distinguish whether the metabolic and inflammatory responses are pain-induced or surgical-induced, it is clear that pain can cause a response. This study aims to investigate the effects of erector spinae plane block on surgery-related stress response with enhanced recovery after cardiac surgery protocol.
详细描述
The Enhanced Recovery After Cardiac Surgery (ERAS Cardiac) program includes a perioperative multimodal, opioid-sparing pain management plan as an essential component of any comprehensive program. A multimodal pain management plan is nonopioid systemic analgesic agents, regional and local anesthetic techniques, and judicious use of opioids. This study aims to examine inflammatory and hematological parameters in patients who underwent cardiac surgery with ERAS, with and without preoperative bilateral erector spinae plane block (ESP). For this purpose, the presence of an obstacle ESP block application in the preoperative period will be investigated in patients who are prepared for cardiac surgery according to ERAS principles, and the patient's group will be determined accordingly. An analgesia protocol that does not include a regional technique will be applied to the patient in cases such as the patient's refusal to allow preoperative block and the presence of a situation that does not allow blockage in the block area. The perioperative characteristics of ERAS patients with and without ESP block will be examined, intraoperative lactate, and preop-postoperative hemogram-albumin-C reactive protein parameters will be recorded.
ERAS patients with ESP block: After preparation in accordance with the ERAS protocol, ultrasound-guided bilateral ESP block will be performed with 20 ml of 0.025% bupivacaine at T5-7 levels in patients taken to the operating room in the preoperative period, and will be administered intraoperative low-dose remifentanil infusion and sevoflurane anesthesia.
ERAS patients without ESP block: After preparation according to the ERAS protocol, patients will be administered lidocaine, ketamine, paracetamol, and intraoperative low-dose remifentanil infusion and sevoflurane anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients who will undergo open-heart surgery with ERAS protocol
排除标准
- •Emergency surgeries
- •Patients with allergic reactions to anesthesia and analgesia drugs to be used
- •Patients who do not want to participate in the study voluntarily
- •Severe systemic disease (kidney, liver, pulmonary, endocrine)
- •Substance abuse history
- •History of chronic pain
- •Psychiatric problems and communication difficulties
- •Patients who need revision due to hemostasis in the postoperative period
- •Patients with severe hemodynamic instability due to infection, heavy bleeding, etc.
结局指标
主要结局
Basal measurements- after anesthesia induction
时间窗: After anesthesia induction, an average of 5 minutes
After induction of anesthesia, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.
Second measurements- after cardiopulmonary bypass initiation
时间窗: After cardiopulmonary bypass inititation, an average of 5 minutes
After cardiopulmonary bypass initiation, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.
Third measurements- during cardiopulmonary bypass, at lowest temperature
时间窗: During cardiopulmonary bypass, an average of 10 minutes
During cardiopulmonary bypass, at lowest temperature, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.
Fourth measurements- end of cardiopulmonary bypass
时间窗: At the end of cardiopulmonary bypass, an average of 10 minutes
At the end of cardiopulmonary bypass, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.
Fifth measurements- end of surgery
时间窗: At the end of surgery, an average of 20 minutes
At the end of surgery, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.
次要结局
- Preoperative albumin(The day before surgery, 24 hours)
- Postoperative albumin(6 hours after surgery)
- Preoperative complete blood count(The day before surgery, 24 hours)
- Postoperative C reactive protein(6 hours after surgery)
- Postoperative complete blood count(6 hours after surgery)
研究者
Eda Balci
Medical Doctor
Ankara City Hospital Bilkent