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临床试验/NCT05538429
NCT05538429招募中不适用

Comparison of Analgesic Effect and Postoperative Recovery of Serratus Anterior Plane Block Combined With Erector Spinae Plane Block and Thoracic Paravertebral Block After Thoracoscopic Surgery

Zhangyi1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
92
试验地点
1
主要终点
The dose of opioids used

研究概览

简要总结

After thoracoscopic surgery, patients still face moderate to severe pain. How to effectively control pain and promote postoperative recovery of patients is a challenging problem. Thoracic paraspinal block is effective in controlling pain after thoracoscopic surgery, but it also carries the risk of difficulty in operation and puncture of the pleura. In recent years, erector spinal plane block and serratus anterior plane block have been used for postoperative analgesia after thoracoscopic surgery. The purpose of this study was to explore whether erector spinal plane combined with serratus anterior plane block can replace thoracic paravertebral block and provide a more complete analgesia after thoracoscopic surgery. Therefore, this study is of great clinical significance.

详细描述

In a double-blind randomized controlled study, investigators allocated 92 patients undergoing VATS to either SAPB Combined With ESPB or TPB, with both groups receiving otherwise standardized treatment, including multimodal analgesia. The primary outcome was 24-hr opioid consumption. Secondary outcomes included the number of survival analgesia at 1, 2, 4, 8, and 24 hours postoperatively ,VAS scores was assessed during resting and coughing statuses at 1, 2, 4, 8, and 24 hours postoperatively, pulmonary function indexes before and 1, 4, 24 hours after surgery , QOR-15 scores before and 24 hours after surgery, postoperative complications and recovery time nodes drainage tube removal time, discharge time.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American ASA Grade I-III;
  • Age: 18 ~ 70 years old;
  • 3 BMI 19 ~ 28kg/m2;
  • Patients with elective thoracoscopic partial pneumonectomy under general anesthesia;
  • 5 Informed Consent has been signed.

排除标准

  • Use opioid analgesics on a daily basis or have a history of opioid abuse;
  • History of ipsilateral thoracotomy;
  • Allergic to any of the drugs used in the study, or have a history of drug allergy;
  • Mental or nervous system diseases, motor or sensory deficits;
  • 5 there is coagulation dysfunction;
  • Cognitive dysfunction, unable to cooperate with research;
  • Severe renal, hepatic or cardiac dysfunction;
  • Chest wall and spine trauma, infection, deformity and other cases where nerve block cannot be performed;
  • Participated in other clinical trials within the 3 months prior to study inclusion;
  • Investigators consider other reasons unsuitable for clinical trial participants;
  • Patients refuse to participate.

结局指标

主要结局

The dose of opioids used

时间窗: 24 hours after surgery

dosage of analgesic pump

次要结局

  • The dose of opioids used(1hour, 2hours, 4hours, 8hours and 48hours postoperatively after surgery)
  • pulmonary function indexes(Preoperative, postoperative 1hour, postoperative 4hours and postoperative 24hours)
  • Postoperative complications and recovery time nodes(follow up patients for an average of half a month)
  • The number of survival analgesia(1hour, 2hours, 4hours, 8hours, 24hours and 48hours after surgery)
  • VAS scores at resting and coughing state(1hour, 2hours, 4hours, 8hours, 24hours and 48hours after surgery)
  • QOR-15 scores(before and 24 hours after surgery)

研究者

发起方
Zhangyi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zhangyi

Professor

Tongji Hospital

研究点 (1)

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