Efficacy of Erector Spinae Plane Block and Pectoral Fascia Block in Patients Undergoing Mitral Valve Repair Through the Right Mini-thoracotomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Total consumption of oxycodone
研究概览
简要总结
Patients scheduled for minimally invasive mitral valve repair. Each patient will be treated with intravenous (i.v.) oxycodone - patient-controlled analgesia (PCA). Patients will be allocated to one of the groups: erector spinae plane (ESP) block or EPS with pectoral fascia (PECS) block.
详细描述
Only patients who are qualified for an elective procedure of mitral valve replacement may participate in the study. Each patient will be anesthetized generally. The same drugs will be used in each stage of anesthesia. The induction: etomidate, remifentanil, rocuronium, scolina as required. The maintenance: sevoflurane, remifentanil, rocuronium. The emergence: oxygen, sugammadex or neostigmine a required.
Patients will be randomly allocated to one of two groups: ESP or PECS. Among the patients from ESP group will have ESP blockade before the induction of general anesthesia. ESP blockade will be performed under ultrasound control. A single-shot technique will be used with 0.375 % solution of ropivacaine: 0.1 mL per patient KG. The maximum dose is 20 mL.
Patients from PECS group will receive ESP block and PECS I and II type block with 0.375 % solution of ropivacaine (up to 20 mL of local anesthetic).
Each patient, before the end of surgery, will be administered i.v. 0.1 mg of oxycodone. PCA with oxycodone (1mg/mL) will be utilized during the postoperative period: 7-minute interval. This is standard protocol in the investigator's department.
Only patients who are successfully awakened after the procedure may participate in the study.
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
- Single (Participant)
盲法说明
Single (Participant)
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
- •Scheduled mitral valve replacement surgery
- •obtained consent
排除标准
- •allergy to oxycodone and local anesthetics
- •depression, antidepressant drugs treatment
- •usage of painkiller before surgery
- •addiction to alcohol or recreational drugs
- •prolonged postoperative ventilation (over 2 hours)
研究组 & 干预措施
ESP
Before the induction of general anesthesia, Erector Spinae Plane (ESP) blockade will be done. Postoperative analgesia is provided with intravenous oxycodone. Patient-controlled analgesia pump (PCA) will be used for this purpose.
干预措施: Erector Spinae Plane blockade (Procedure)
ESP
Before the induction of general anesthesia, Erector Spinae Plane (ESP) blockade will be done. Postoperative analgesia is provided with intravenous oxycodone. Patient-controlled analgesia pump (PCA) will be used for this purpose.
干预措施: Oxycodone (Drug)
ESP
Before the induction of general anesthesia, Erector Spinae Plane (ESP) blockade will be done. Postoperative analgesia is provided with intravenous oxycodone. Patient-controlled analgesia pump (PCA) will be used for this purpose.
干预措施: general anesthesia (Procedure)
ESP
Before the induction of general anesthesia, Erector Spinae Plane (ESP) blockade will be done. Postoperative analgesia is provided with intravenous oxycodone. Patient-controlled analgesia pump (PCA) will be used for this purpose.
干预措施: paracetamol (Drug)
PECS
Before the induction of general anesthesia, Erector Spinae Plane (ESP) block and Pectoral fascia type I and II will be done. Postoperative analgesia is provided with intravenous oxycodone. Patient-controlled analgesia pump (PCA) will be used for this purpose.
干预措施: Erector Spinae Plane blockade (Procedure)
PECS
Before the induction of general anesthesia, Erector Spinae Plane (ESP) block and Pectoral fascia type I and II will be done. Postoperative analgesia is provided with intravenous oxycodone. Patient-controlled analgesia pump (PCA) will be used for this purpose.
干预措施: Pectoral Fascia block (Procedure)
PECS
Before the induction of general anesthesia, Erector Spinae Plane (ESP) block and Pectoral fascia type I and II will be done. Postoperative analgesia is provided with intravenous oxycodone. Patient-controlled analgesia pump (PCA) will be used for this purpose.
干预措施: Oxycodone (Drug)
PECS
Before the induction of general anesthesia, Erector Spinae Plane (ESP) block and Pectoral fascia type I and II will be done. Postoperative analgesia is provided with intravenous oxycodone. Patient-controlled analgesia pump (PCA) will be used for this purpose.
干预措施: general anesthesia (Procedure)
PECS
Before the induction of general anesthesia, Erector Spinae Plane (ESP) block and Pectoral fascia type I and II will be done. Postoperative analgesia is provided with intravenous oxycodone. Patient-controlled analgesia pump (PCA) will be used for this purpose.
干预措施: paracetamol (Drug)
结局指标
主要结局
Total consumption of oxycodone
时间窗: From the end of anesthesia till 24 hour postoperatively
The cumulative consumption of oxycodone during 24 hour from the end of anesthesia. Less is better, less intense pain.
次要结局
- Pain intensity measured by VAS(From the end of anesthesia till 24 hour postoperatively)
研究者
Michał Borys
Principal Investigator
Medical University of Lublin