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临床试验/NCT05200689
NCT05200689Unknown不适用

Post-Operative Kinesio Taping Impact on Pain in Thoracotomy vs Thoracoscopy

Al-Quds University7 个研究点 分布在 5 个国家目标入组 310 人开始时间: 2022年1月9日最近更新:
适应症

试验速览

阶段
不适用
入组人数
310
试验地点
7
主要终点
Postoperative Pain: Change in VAS Pain Scale

研究概览

简要总结

The project is of a comparative nature. It seeks to study pain reduction following two forms of chest surgery and compare results between both procedures. It will use kinesio taping as the studied pain reducer. It will involve 4 study groups, 2 per surgical procedure, and among those 2 main groups, 2 subgroups each where 1 has kinesio taping and the other doesn't.

With this, the project hopes to offer new forms of pain reduction that are more cost effective and are associated with less adverse effects. Furthermore it would decrease pain killer intake which is a contemporary challenge of medicine.

详细描述

Fueled by its utmost importance, thoracic surgery has quickly evolved to produce techniques that improve its means and purposes, but most importantly fully harness its goals. Thoracic surgeries include multiple techniques; thoracotomy and thoracoscopy are among the most highly applied types since they are involved in the diagnosis and treatment of lung cancer, cardiovascular disease, and other comorbidities, but most notably are the hallmark of lung resection.

Thoracotomy is surgery to open the chest. This procedure involves an incision in the thorax, between the ribs, to allow for operating on the lungs. A surgeon can use this incision to remove part of or the whole lung. Usually, this is done to treat lung cancer. Sometimes it's used to treat problems with the heart or other structures in the chest, such as the diaphragm. On the other hand, thoracoscopy is a surgical procedure for the examination of the chest, particularly the pleural cavity by means of a thoracoscope. Thoracoscopy can be done as part of the Video-Assisted Thoracic Surgery procedure (VATS). Uniportal VATS makes use of 1 single port incision.

Both thoracoscopy and thoracotomy have been thoroughly studied by recent literature, and even compared. However, when properly surveyed, research is found to be lacking in the field of morbidity reduction, namely when concerning pain management. This is quite alarming as the main complication of thoracic surgeries is pain, which may even extend to post-thoracotomy pain syndrome (PTPS), which occurs in 21 to 61% of patients and may persist up to four to five years after surgery in 30% of patients.

As pain is a major debilitating factor to the patient, decreasing it will serve as a major improvement for patient morbidity and satisfaction.

Analgesics are still considered one of the most effective approaches in terms of pain relief. Though the use of analgesics has been recently viewed to approach the limits of abuse, both economically and pharmacologically. This includes the epidemic overuse of opioids and such. This issue has also been at the forefront of recent medical research and at the top of the medical world's agenda for the past few years. This calls the scientific community to find a proper solution.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Single port VATS thoracoscopies
  • Patients that undergo thoracotomy or thoracoscopy at associated centers
  • Patients within the age range (18-64) years.

排除标准

  • Preexisting conditions
  • Certain surgical complication
  • KT and analgesics-related contraindications
  • Patients that offer logistic difficulties.
  • Patients that suffer from recent chest trauma (Within 6 months), pre-existing chest pain
  • Rib resection, pleuralesis, parietal pleura involvement in the surgery
  • Surgeries with increased involvement of the chest, vertebrobasilar insufficiency
  • Inflammatory diseases
  • Neurologic diseases
  • Congenital diseases
  • Fractures, dislocations, infections
  • Dural perforations, spinal cord damage with abscess development due to nerve block
  • Patients who have contraindications to KT, especially those who suffer from DVT (DVT: Deep Vein Thrombosis), skin Pathologies, and diseases, especially relating to the chest area
  • Patient with congestive heart failure
  • Patients that experience skin sensitivity or allergy to the Kinesio taping
  • Patients who undergo other forms of pain reduction therapy such as massages
  • The lack of patient consent

结局指标

主要结局

Postoperative Pain: Change in VAS Pain Scale

时间窗: 21 days

Degree of change in postoperative pain. It will be measured 5 times. Postoperative pain will be measured via the VAS pain scale. It will also be estimated based on the patients' request for further analgesia. The VAS Scale stands for: Visual Analog Scale. Minimum Score: 0 Maximum Score: 100 Higher scores signify worse pain and thus a worse outcome.

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 (7)

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