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临床试验/NCT03731221
NCT03731221已完成早期 1 期

A Comparison of Combined Pectoral Fascial Plane and Serratus Anterior Plane Blocks With Bupivacaine HCL With and Without Liposomal Bupivacaine for Video Assisted Thoracic Surgery

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 196 人开始时间: 2018年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
196
试验地点
1
主要终点
Overall benefit of analgesia score

研究概览

简要总结

Patients will be randomized the day of surgery upon presentation to the operating room to either a treatment group (PECSII/SAP blocks with bupivacaine HCl plus liposomal bupivacaine) or a control group (PECSII/SAP blocks with bupivacaine HCl plus preservative free normal saline) using secure web-based randomization. Assignments will be based on computer-generated code. Clinicians will not be blinded to the intervention, but all outcomes will be assessed by research personnel who are blinded to the group assignment.

详细描述

Anesthetic care will be performed in a usual manner in Cleveland Clinic thoracic surgical patients. This includes the use of standard ASA monitors and may include the use of arterial or central venous pressure monitoring, trans-esophageal echocardiography, and lung isolation using a bronchial blocker or a double lumen endotracheal tube. Medication administration for induction and maintenance of anesthesia will also be consistent with usual care and will include intravenous opioids such as fentanyl and hydromorphone. Intravenous lidocaine boluses will not be administered upon induction of anesthesia. Pressure control ventilation will be utilized with a tidal volume not exceeding 6-10 ml/kg ideal body weight during two-lung ventilation and 5-7 ml/kg ideal body weight during one-lung ventilation. A conservative fluid management strategy will be employed in all cases. Patients not extubated at the end of the procedure will be sedated with propofol. Surgical procedures will be performed in their usual manner.

The anatomic basis for chest wall analgesia has been described in detail previously. The investigators describe the conduct of the blocks as used for VATS procedures at the investigator's institution. The patients randomized to the treatment group will all receive PECSII and serratus blocks containing bupivacaine HCl and liposomal bupivacaine. The control group will receive PECSII and serratus blocks with bupivacaine HCl adjusted to a similar volume. The PECS/serratus blocks will be performed with the patient under the general anesthesia and before incision. If this is not possible due to surgical urgency, the block will be placed at end of surgery.

Patients will be positioned supine, and prepped and draped in a sterile fashion. An ultrasound probe will be placed just below the clavicle in the mid-clavicular line.

For the PECS II block, the probe will be scanned inferiorly and laterally until the plane between the pectoralis minor and serratus muscle is identified. The serratus muscle can be clearly seen coursing over the ribs, while the intercostal muscles are seen in the interspaces between the ribs. Once the plane is identified the needle is again advanced in an "in-plane" fashion. Once the needle location is confirmed by normal saline hydro-dissection, a 15-20 cc of local anesthetic solution is administered into the space.

With the patient in a supine position, a back roll will be placed under the operative side to achieve a slightly lateral tilt. The arm is abducted to expose the costal margin. The positioning and prepping is done prior to the PECS block to avoid repositioning. The ultrasound probe is scanned laterally from the pectoralis to the axillary region at approximately the level of the 5th rib. The plane between the serratus muscle and the latissimus dorsi muscle is identified and the needle advanced in an "in-plane" fashion until the tip is between the muscles (superficial SAP block). A small bolus of 0.5 cc of normal saline is used for hydro-dissection of the tissue planes to confirm that the needle is not intramuscular. The needle is then aspirated every 5 cc as 40 cc of local anesthetic solution is deposited into the plane. As these are field blocks, adequate volume of infiltration is important in achieving optimal 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

Anesthesiologists will not be blinded to the intervention, but all outcomes will be assessed by research personnel who are blinded to the group assignment.

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 18-85 years of age
  • Procedures using thoracic access ports or miniature thoracotomy incisions such as video assisted thoracic surgical (VATS) or robotic anatomic pulmonary resection (lobectomy, bilobectomy, and segmentectomy)

排除标准

  • Weight less than 50 kg
  • Pregnancy or lactation
  • Emergency surgery and patients transferred from the ICU to the operating room
  • Redo thoracic surgery or post-operative reoperation within 72 hours of index procedure (including minor chest wall procedures including tube thoracostomy, thoracentesis or percutaneous drain placement)
  • Anticipated endotracheal intubation > 24 hours
  • Non-study nerve block that provides analgesia to the intercostal nerves
  • Active systemic or cardiopulmonary infection
  • Mechanical circulatory support devices
  • Allergy or contraindication to study local anesthetics
  • More than 15 mg/day morphine equivalents on at least 15 of the 30 preoperative days
  • Poorly controlled psychiatric disorders
  • Clinically important current neurologic deficit e.g. spinal cord injury, paralysis of extremity, any neurologic deficit in the region of the block
  • Active liver disease or cirrhosis
  • Pacemaker generator or breast implants ipsilateral to surgery
  • Previous participation in this study
  • eGFR <30 or chronic kidney disease

研究组 & 干预措施

Bupi HCl plus liposomal bupi

Experimental

PECSII/SAP blocks with bupivacaine HCl plus liposomal bupivacaine

干预措施: Bupi HCI and lipo bupi (Drug)

Bupi HCl plus saline

Active Comparator

PECSII/SAP blocks with bupivacaine HCl plus preservative free normal saline

干预措施: Bupi HCI (Drug)

结局指标

主要结局

Overall benefit of analgesia score

时间窗: Postoperative day 3

The overall benefit of analgesia score (OBAS) is based on 7 questions and ranges from 0 to 28 points

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Donn Marciniak

Enterprise Chair, Dept of Intensive Care and Resuscitation

The Cleveland Clinic

研究点 (1)

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