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临床试验/NCT03628040
NCT03628040Unknown3 期

Erector Spinae Plane Block for Video-assisted Thoracoscopic Surgery: a Randomized Controlled Trial

Lawson Health Research Institute0 个研究点目标入组 82 人开始时间: 2019年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
82
主要终点
Opioid consumption in IV morphine equivalents

研究概览

简要总结

Video-Assisted Thoracoscopic Surgery (VATS) is a minimally invasive surgery that utilizes camera based scopes and specialized instruments through keyhole sized ports to remove lesions in the thoracic cavity. Despite reduced surgical trauma compared to the traditional thoracotomy approach, patients continued to experience moderate to severe postoperative pain. Pain medication such as opioids is commonly utilized for postoperative pain control but is associated with side effects. The use of nerve blocks, such as the recently described erector spinae plane block (ESPB) has been shown in case reports to reduce pain and thus has the potential to improve patient recovery and decrease the risk of pulmonary complication. This study aims to investigate the analgesic effect of ESPB in managing pain following VATS.

详细描述

VATS is a minimally invasive surgical technique to remove intrathoracic lesions. Using a camera based scope and specifically designed instruments, the surgery can be initiated with three "key-hole" sized incisions. At the end of the surgery, an incision is enlarged to allow removal of surgical specimen. Chest tubes are inserted at the end of procedure and sutured in between the ribs.

While acute pain after VATS is less than the traditional thoracotomy, patients still experience moderate amount of pain within the first 24 hours. Source of pain may be from diaphragm irritation, surgical incisions and chest tubes. Because of its origin on the chest wall, pain from VATS worsens with breathing. When pain is poorly controlled, it will lead to a shallow breathing pattern called "splinting" and this can progress to respiratory distress or failure. Given the high incidence of smoking history in this patient population, many would have presented with poor baseline respiratory function. Therefore, it is important to provide good pain control to allow deep breathing and cough to reduce respiratory complications[1][2].

Despite the smaller incisions, the incidence of chronic post-surgical pain (CPSP) after VATS is surprisingly similar to thoracotomy. The mechanism may be due to nerve compression by the trocar, an instrument inserted between the ribs to allow smooth manipulation of camera and surgical instruments in the thoracic cavity. Additionally, poorly controlled acute pain has also been postulated to lead to the development of CPSP, further emphasizing the importance of good analgesia[1].

Many regional analgesia techniques have been tried to improve postoperative analgesia. Thoracic epidural analgesia (TEA) remains the gold standard of pain control after thoracic surgery. Although it provides superior analgesia, its use is hindered by the rare but serious complication of epidural hematoma and abscess which may cause paralysis. Further, pain from VATS tends to be short-lived (less than 24 hours), making the risk to benefit ratio less ideal for TEA. An alternative to TEA is paravertebral block (PVB). Compared to TEA, it causes less hypotension and hematoma or abscess at the paravertebral space may be less consequential. Nevertheless, PVB is a deep block and is technically demanding which limits its wide adoption[3].

Erector spinae plane block (ESPB) is a novel nerve block that has been used for analgesia for surgeries of the chest and abdominal wall. Using a bony structure, the transverse process, as the end point, the block needle is very unlikely to cause injury to vital structures as is possible with TEA or PVB (for examples, the spinal cord, lungs and blood vessels). It is also technically easy to perform. ESPB has only been reported in case series but so far, no adverse events such as hypotension, hematoma or infection has been reported. ESPB has also showed promise in managing CPSP after thoracic surgery in a small case series[4].

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

The randomization sequence will be computer-generated. Allocation concealment will be carried out via concealed assignments in opaque, sealed, and consecutively numbered envelopes. Blinding will be achieved by sham blocks. After patient allocation, a research assistant not participating in the clinical care and outcome assessment will prepare a syringe of 30 mL 0.5% ropivacaine or normal saline labeled "study drug" which will then be passed on to one of the investigators (CL or KK) who are blinded to patient allocation. Patients who are allocated to the "block" group (group B) will receive 0.5 ropivacaine with the ESPB while the "control" group (group C) will receive normal saline. In addition to ESPB, both group will receive multimodal systemic analgesia including acetaminophen, non-steroidal anti-inflammatory medication and an intravenous (IV) opioid patient-controlled analgesia (PCA) that provides IV opioids on patient-demand.

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
  • Scheduled for an elective VATS
  • American Society of Anesthesiologists (ASA) physical status I to III

排除标准

  • Patient refusal or inability to provide consent
  • Chronic pain conditions
  • Daily opioid use > 60 mg of oral morphine equivalents
  • Cognitive or psychiatric condition that makes it challenge to assess pain
  • Conversion to open thoracotomy
  • Allergy to any of the drugs used in this study
  • Contraindication to nerve blocks such as infection, severe coagulopathy or pre-existing neuropathy
  • Significant systemic cardiac, respiratory, hepatic or renal diseases
  • Postoperative admission to intensive care unit

研究组 & 干预措施

Sham Block

Sham Comparator

Patient will receive a single shot of normal saline 20 mL injected at the erector spinae plane

干预措施: Normal saline (Drug)

Erector Spinae Block

Active Comparator

Patient will receive a single shot of Ropivacaine Injection [Naropin] 0.5% 20 mL injected at the erector spinae plane

干预措施: Ropivacaine Injection [Naropin] (Drug)

结局指标

主要结局

Opioid consumption in IV morphine equivalents

时间窗: First postoperative 24 hour

All source of opioid

次要结局

  • Incidence of vomiting(Up to 1 week)
  • Incidence of drowsiness(Up to 1 week)
  • Opioid consumption in IV morphine equivalents(Second postoperative 24 hours)
  • Area under curve of pain score(Second postoperative 24 hour)
  • Post-anesthetic recovery length of stay(up to 12 hours)
  • Hospital length of stay(Up to 1 week)
  • Incidence of nausea(Up to 1 week)
  • Incidence of pruritus(Up to 1 week)
  • Incidence of mechanical ventilation(during the first 24 hours)
  • Incidence of infection at block injection site(Up to 1 week)
  • Incidence of paresthesia in the area covered by block(Up to 1 week)
  • Incidence of hypoxia(during the first 24 hours)
  • Incidence of tachypnea(during the first 24 hours)
  • Incidence of symptomatic hematoma at block injection site(Up to 1 week)

研究者

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

Cheng Lin

Assistant Professor

Lawson Health Research Institute

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