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临床试验/NCT06488014
NCT06488014已完成不适用

Comparison of the Effect of Preoperative and Postoperative Erector Spina Plan Block and Paravertebral Block on Postoperative Pain in Video Assisted Thoracic Surgery (VATS)

Ankara University2 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2024年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Acute postoperative pain

研究概览

简要总结

The aim of this prospective controlled randomised clinical trial was to identify the analgesic method that is more effective than two different regional analgesia techniques routinely used for pain control after video-assisted thoracic surgery (VATS).

The effects of paravertebral block and erector spina plan (ESP) block on acute pain, need for additional analgesics and incidence of chronic pain after video-assisted thoracic surgery (VATS) will be compared before surgical incision (pre-emptive) and at the end of surgery.

The aim is to demonstrate that the ESP block, a relatively newer method in the literature, provides analgesia comparable to that of the paravertebral block.

详细描述

Pain after thoracic surgery is common and usually severe due to factors such as surgical incisions, damage to the lung tissue and ribs, and irritation of the pleura and intercostal nerves by the chest tube. Thoracotomy is one of the most painful surgical operations and the incidence of chronic pain has been reported to be approximately 65% in most studies. Video-assisted thoracic surgery (VATS) has become more common in recent years. Compared with open thoracotomy, VATS reduces postoperative pain, morbidity and length of hospital stay, which is associated with a smaller extent of tissue trauma. However, VATS still causes moderate to severe acute postoperative pain and chronic pain with an incidence reported in the range of 25-35%.

Accelerated rehabilitation is important in thoracic surgery. Postoperative outcomes are affected by the patient's ability to get out of bed and participate in physical respiratory therapy exercises. Inadequate analgesia is also directly related with postoperative pulmonary functions. Pain may lead to atelectasis, hypoxaemia and pneumonia as a result of ineffective cough and thus inadequate sputum expulsion.

Pain management after VATS is important because it may reduce postoperative complications. Systemic analgesic methods using intravenous (iv) drugs such as lidocaine, nonsteroidal anti-inflammatory drugs, steroids, alpha2-adrenergic agonists or N-methyl-D-aspartate (NMDA) antagonists and thoracic epidural analgesia, The multimodal analgesia approach in which regional analgesia methods such as paravertebral block, erector spina plan (ESP) block, and serratus anterior plan block are combined is an approach with proven efficacy in recent studies and guidelines. Regional analgesia has the potential to reduce postoperative acute pain and chronic pain and to increase early postoperative recovery.

Although thoracic epidural anaesthesia (TEA) is considered the gold standard for the treatment of postoperative pain in thoracic surgery, the presence of possible side effects such as dura perforation, nerve damage, epidural bleeding, risk of hypotension and urinary retention has shown that VATS may require less invasive analgesia. Thoracic paravertebral block (TPVB) provides unilateral thoracic analgesia comparable to TEA. In addition, it is not only less invasive than TEA, but also can maintain haemodynamic stability and carries a lower risk of complications. According to the Enhanced Recovery After Surgery (ERAS) guidelines and the Procedure-specific postoperative pain Management (PROSPECT) group, TPVB is recommended as the primary method of regional analgesia for thoracic surgery.

Paravertebral local anaesthetic may spread to multiple levels into the epidural and intercostal spaces, blocking the spinal nerve and sympathetics, resulting in segmental block and ipsilateral sympathectomy. Major risks or complications of PVB include pneumothorax, hypotension due to bilateral PVBs, dural puncture and possible risks associated with epidural injections, including epidural abscess, epidural haematoma. In recent years, there has been increasing interest in fascial plane blocks, which involve spreading large amounts of local anaesthetics into the fascial planes through which nerves pass or communicate with other areas containing the nerves of interest. The erector spinae plane block is the most widely investigated fascial plane block that is most suitable for thoracic surgery. It is technically easier to perform and theoretically has lower risks of serious adverse events associated with TEA and PVB, including epidural haematoma or abscess or pneumothorax, and is less likely to cause sympathectomy or hypotension. ESPB targets the facial plane between the erector spinae muscles and the posterior border of the transverse processes, blocking the dorsal branches of the spinal nerves and potentially spreading anteriorly into the adjacent paravertebral and epidural spaces, blocking the ventral rami and sympathetic chain.

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, Care Provider)

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

  • >18 years
  • Patients with a VATS (video-assisted thoracic surgery) plan

排除标准

  • Under 18 years old
  • Patients under 40kg and BMI over 35
  • Allergic to the drugs to be used in the study
  • Patients with a history of chronic painkiller use
  • Patients who refused to participate in the study

研究组 & 干预措施

Group E

Active Comparator

Erector spina plan block : Under USG guidance, local anaesthetic will be administered to the fascial plane between the erector spinae muscle and the transverse process.

干预措施: Erector spina plan block (ESP) (Procedure)

Group P

Active Comparator

Paravertebral block: USG-guided local anaesthetic administration to the side of the vertebral body close to where the spinal nerves exit from the intervertebral foramen.

干预措施: Paravertebral block (Procedure)

结局指标

主要结局

Acute postoperative pain

时间窗: 4 month

Lower pain scores with erector spina plan block in pain control after acute thoracoscopy (using visual analogue scale, lowest value (no pain): 0, highest value (most severe pain): 10, lower values are considered as good results)

次要结局

  • Chronic postoperative pain(6 month)

研究者

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

Hatice Güneş Yeşilova, MD

Research assistant

Ankara University

研究点 (2)

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