Serratus Planus Block After Minimally Invasive Cardiac Surgery: a Prospective Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Postoperative Pain Score: VAS 0-10
研究概览
简要总结
Many patients receiving MICS (minimally invasive cardiac surgery) suffer from significant postsurgical pain. While systemic analgesic therapy has been proven to be insufficient in a great number of patients, significant unwanted side effects might occur. Therefore, the investigation of peripheral nerve blocks such as SAPB with potential for high benefit and low risk for adverse effects as new treatment options for thoracotomy-pain is relevant. Previous randomized double-blind investigations of this novel technique are lacking. At this moment our department's current standard of care is that, SAPB is performed in patients after MICS in our department if the treating anesthetist is experienced in the procedure and the patient receives i.v. analgesia only without nerve block is he or she is not. If we are able to show a benefit for patients in the SAPB arm, the nerve block may constitute a new standard of care for all MICS patients no only in our department but also after MICS in general.
Patients ≥18 years of age, being treated in the cardiothoracic ICU after elective cardiac surgery performed via lateral minithoracotomy (mitral valve, tricuspid valve, atrial septal defect closure) will be included after signed informed consent before surgery. Allocation concealment is guaranteed by opening of the concealed envelope and performance of the ultrasound guided SAPB or ultrasound only by medical personnel not involved in any of the study procedures.
Randomization will be carried out by a web-based software ('randomizer,). The intervention will be performed after ICU arrival but under sedation and analgesia before extubation to minimize patient discomfort and to ensure double blinding.
Efficacy will be evaluated using Pain Scoring by visual analogue scale (VAS), opioid requirements, postoperative complications, need for rescue analgesia, lung function tests and markers of myocardial stress and inflammatory parameters in the early postoperative period according to our current protocol in the ICU.
详细描述
As described in the Brief Summary, patients after MICS may suffer from significant post surgical pain, while SAPB is a promising measure for pain relief and avoidance of opioid associated side effects, high quality data after cardiac surgery are lacking.
This singlecenter, prospective, randomized, double-blinded, clinical trial is conducted at the department for cardiothoracic anesthesia of the Medical University of Vienna, Austria, from January 2023. The study is performed in accordance with the Helsinki Declaration. The study protocol was approved by the Institutional Review Board (EC number 1012/2021) and registered at the European Union Clinical Trials Register (EudraCT trial no. 2020-005220-10). Written informed consent will be obtained from all eligible patients before surgery.
Eligibility and exclusion criteria are described in detail under "eligibility". Patients could drop out from the study after surgery (and therefore after randomization, which is performed at the end of surgery) if any criteria preventing early weaning and extubation arise (hemodynamically or respiratory instability or bleeding requiring reoperation).
Patient demographics and baseline characteristics including baseline ling function will be collected preoperatively. After arrival in the ICU intraoperative characteristics including length of surgery and intraoperative analgesia requirements will be collected. Pain will be assessed by ICU nurses blinded to the intervention group using a visual analogue scale (VAS). Assessments (described under "outcome measures" in detail, will be conducted following SAPB or standard intravenous pain therapy, performed according to our department's standards.
SAPB In patients randomized to receive SAPB, the block will be performed during respiratory weaning, while patients are intubated and sedated post-surgery to ensure blinding and prevent patient discomfort. Nursing staff and ICU physicians will leave the room during the block to ensure blinding. After achieving good visual conditions of the latissimus dorsi and the serratus anterior muscles using a 13-6 MHz linear array ultrasound transducer (HFL38xi, Sonosite, WA) in a cephalad-to-caudal direction, a 70-mm 22-gauge needle (USC 70 Evolution, Temena, Germany) will be inserted in plane. After confirming an optimal needle tip position by injecting minimal doses of local anesthetic, interfascial injection of 0.4 ml of ropivacaine 0.5%/kg body weight combined with 0.5 µg/kg patient body weight of dexmedetomidine as an adjuvant to prolong block duration will be performed between the serratus anterior and the intercostal muscles. After SAPB, a sterile dressing will be placed on the Block site to ensure blinding.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •18 years of age or more
- •patients undergoing cardiac surgery through a thoracotomy incision
- •patients having surgery performed by a Cardiac Surgeon at the Medical University of Vienna
- •patients being treated in the 16 bed primary cardiothoracic ICU 13B-HTG at the Medical University of Vienna
- •patients being treated in the 4 bed PACU of the cardiothoracic and vascular anesthesia department at the Medical University of Vienna
- •signed patient consent prior to surgery
排除标准
- •patients requiring full sternotomy or emergency surgery
- •Allergy to amid-type local anesthetics
- •patients less that 18 years of age at the time of surgery
- •patients intubated >48h prior to surgery
- •Infection at the site of the Serratus Anterior Plane Block
- •Known bleeding diathesis with increased risk of hematoma at the block site
- •Known opioid abuse
- •Allergy to (metamizole AND acetaminophen) OR (hydromorphone AND Piritramide)
- •Active pulmonary infection at the time of surgery
- •Patient refusal prior to surgery
- •Inability to communicate
- •Patients with known dementia or/and a legal guardian for medical issues
- •Patients unable to understand the study measures and are not able to complete pain assessment forms.
- •Known pregnancy
- •Severe cardiorespiratory disturbances such as high respiratory support (>0,7 FiO2 or driving pressure >25mbar) or high catecholamine support (>0,5mcg/kg/min Norepinephrine and/or >5IE Vasopressin/h) making fast track intensive care with extubation in the first 24 hours after arrival in the ICU and ERAS impossible
- •Patients with unanticipated prolonged intubation >24h after arrival in the ICU
- •Postoperative ECMO support
研究组 & 干预措施
SAPB group
Ultrasound guided Serratus anterior block will be performed according to the analgetic standard in our department.
干预措施: Serratus Anterior Plane Block (Procedure)
Standard i.v. analgesia group
A sterile plaster will be placed on an appropriate site to blind ICU and PACU personnel of the intervention. Patients will receive i.v. analgesia according to the analgesic standard of care in our department.
结局指标
主要结局
Postoperative Pain Score: VAS 0-10
时间窗: 12 hours after successful respiratory weaning
average pain scores (VAS 0-10) reported according to our department's standards immediately after extubation, and if feasible 2, 4, 6,8,10,12 hours after SAPB (or standard i.v. therapy respectively)
次要结局
- rescue analgesia(up to postoperative day 2 after MICS)
- postoperative morphine equivalents(0-12 hours, 12-24 hours, 24-48hours after successful respiratory weaning)
- VAS at 2, 4, 6, 8, 10, 12, 16, 24, 48 hours(2-48 hours after application of the serratus block (SAPB))
- complications from the block, surgery or from postoperative pain(0-48 hours after conclusion of respiratory weaning)
- pulmonary function(0-48 hours after conclusion of respiratory weaning)
- inflammation and myocardial stress parameters(immediately postoperatively, on postoperative day 1 and on postoperative day 2 after MICS)
研究者
Bernhard Zapletal
Anesthesia and Critical care consultant
Medical University of Vienna