跳至主要内容
临床试验/NCT04238455
NCT04238455已完成2 期

Addition of Ultrasound-Guided Serratus Anterior Plane Block to an Enhanced Recovery Pathway for Thoracoscopic Lung Resection: A Randomized Trial

Memorial Sloan Kettering Cancer Center11 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2020年1月22日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
93
试验地点
11
主要终点
number of patients requiring opioids

研究概览

简要总结

The purpose of this study is to see if an anesthesia technique called serratus anterior plane block may provide additional pain relief for the chest wall after lung surgery. The study will evaluate the effect the serratus anterior plane block technique has on the need for opioids after surgery,the level of pain during recovery, and other aspects of recovery, like whether the patient has nausea and their ability to breathe deeply. The effects of the serratus anterior plane block will be compared to the effects of an inactive (sham) block.

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, Investigator)

入排标准

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

入选标准

  • Adult patients ≥ 18 years of age who are capable of giving consent. English language proficiency is required.
  • Undergoing elective minimally invasive (VATS or RATS) anatomic lung resection (segmentectomy or lobectomy) without an epidural.

排除标准

  • Pregnancy (Patients must have a negative pregnancy test within 30 days of the operation)
  • History of documented anaphylaxis or contraindication to local anesthetics
  • History of ipsilateral thoracic surgery. Ipsilateral thoracic surgery indicates any previous thoracoscopic or open (i.e. via thoracotomy) pleural biopsy, lung resection, esophageal surgery, chest wall resection, or other thoracic surgery within the chest cavity. This does not include image-guided lung biopsy. Note: Mediport placement and other procedures performed by a surgeon/proceduralist NOT within the chest cavity are not excluded. Likewise, patients with a history of ipsilateral breast surgery are also not excluded. The purpose is to exclude patients who may have had injury to the intercostal nerves from previous surgery or who have surgically altered anatomy of the hemithorax.
  • Patients undergoing bilateral procedures
  • Weight < 50 kg
  • Chronic sustained-release opioid use for > 2 weeks duration (in the 30 days prior to surgery)
  • Significant cognitive impairment or documented psychological impairment
  • American Society of Anesthesiologists (ASA) physical status > 3
  • Patients may also be excluded from the study if the block is deemed not technically feasible (this may be determined intraoperatively).

结局指标

主要结局

number of patients requiring opioids

时间窗: within 24 hours post-operation

Assessment of this outcome will be performed by abstracting total dosage of opioids administered during this time period from the electronic medical record (EMR). Opioid dosages will be converted to intravenous morphine sulfate equivalent.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (11)

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