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临床试验/NCT05337956
NCT05337956Unknown不适用

Evaluation of the Ultrasound-guided Erector Spinae Plane Block Using Catheter for Postoperative Analgesia in Video-assisted Thoracoscopy: A Prospective, Randomized, Controlled Clinical Trial

Security Forces Hospital1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2022年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
34
试验地点
1
主要终点
24 hours opioid consumption

研究概览

简要总结

Different modalities ranging from patient controlled analgesia (PCA) to different regional blocks have been used to control postoperative pain after thoracic surgeries. Thoracic epidural analgesia and paravertebral blocks are effective modes of pain relief but have the risks of severe complications and side effects which include severe hypotension, nerve injury or spinal cord injury, vascular injury and pleural injury etc.

Erector spinae plane block (ESPB) is relatively new regional technique which was described by Forero et al in 2016. Several studies have demonstrated an effective role of ESPB in controlling pain for thoraco-abdominal surgeries which include breast surgery, thoracic surgery and upper GI laparoscopy. Shim et al in their study showed that ESPB significantly reduced pain score in first 6 hours postoperatively in patients who underwent VATS. The aim of this study is to evaluate the effect of ESPB using catheter on postoperative 24 hours opioid consumption in video-assisted thoracoscopy (VATS)

详细描述

Video-assisted thoracoscopic surgery (VATS) is more commonly used technique nowadays in thoracic surgery. This technique is associated with lesser postoperative pain, better postoperative pulmonary function, decreased mortality and shorter hospital stay. However, patients can have severe and prolonged postoperative pain following VATS. Homma et al reported that 18.8 % of patients have persistent pain following VATS. Acute postoperative pain is considered to be one of strong predictor of persistent pain postoperatively.

Different modalities ranging from patient controlled analgesia (PCA) to different regional blocks have been used to control postoperative pain after thoracic surgeries. Thoracic epidural analgesia and paravertebral blocks are effective modes of pain relief but have the risks of severe complications and side effects which include severe hypotension, nerve injury or spinal cord injury, vascular injury and pleural injury etc.

Erector spinae plane block (ESPB) is relatively new regional technique which was described by Forero et al in 2016. Several studies have demonstrated an effective role of ESPB in controlling pain for thoraco-abdominal surgeries which include breast surgery, thoracic surgery and upper GI laparoscopy. Shim et al in their study showed that ESPB significantly reduced pain score in first 6 hours postoperatively in patients who underwent VATS. The objective of this study is to investigate the role of ESPB using catheter in reducing opioid requirements in first 24 hours after VATS.

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, 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

  • All patients aged 18-70 years, ASA 1 to 3 undergoing video-assisted thoracoscopy

排除标准

  • Patient refusal, Contraindication to regional anesthesia, Allergy to local anesthesia, bleeding diathesis, use of anticoagulants or corticosteroids, inability to operate PCA, psychiatric disorders or use of psychiatric medications, conversion to open thoracotomy

结局指标

主要结局

24 hours opioid consumption

时间窗: 24 hours

How much opioid (morphine equivalents) in milligrams was consumed in 24 hours after surgery

次要结局

  • Numerical rating score (NRS) pain score at 15 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 12 hours, 18 hours and 24 hours after surgery both at rest and when coughing(first 24 hours)
  • Postoperative shoulder pain(24 hours)
  • Postoperative nausea and vomiting(24 hours)

研究者

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

Anwar ul Huda

Consultant Anesthesia

Security Forces Hospital

研究点 (1)

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