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临床试验/NCT03228056
NCT03228056Unknown不适用

Postoperative Pain After Single Port, Two Ports and Three Ports Video-assisted Thoracic Surgery Lobectomy in Cancer Patients: A Randomized Controlled Trial

Pulmonary Hospital Zakopane2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
2
主要终点
pain intensity

研究概览

简要总结

This single-center, prospective, randomized controlled trial was designed to assess and compare the postoperative pain after VATS lobectomy performed though one, two and three incisions. The primary outcome measure is pain intensity measured in VAS scale. The secondary outcome measure is cumulative morphine consumption up to 72 hours after surgery

详细描述

The best VATS technique for lobectomy has not been well defined yet. Most of the authors describe the VATS approach to lobectomy via 2 to even 4 incisions. The final step in the evolution of the technique is the use of a single-port approach. If conventional multiportal VATS is superior to open thoracotomy by virtue of minimizing surgical access trauma, then further reduction in such access trauma should yield even greater benefits. Therefore, reducing the number of wounds from three or four to just one, should, in theory, lead to less pain, paresthesia, and morbidity as well as faster recovery. However, critics of the uniportal VATS approach may raise concerns about whether this most minimally invasive surgical approach for lung surgery may compromise safety and treatment efficacy. In addition, there's the concern about true invasiveness of the procedure. This prospective, randomized controlled trial was designed to compare the postoperative pain after VATS lobectomy performed through one, two and three incisions. The primary outcome measure is pain intensity measured in VAS scale. The secondary outcome measures are cumulative morphine consumption up to 72 hours after surgery in 4-hour intervals and dynamic spirometry (PEF, FEV1 and FVC) measured daily at the bedside up to 72 hours after surgery. All patients will receive the same regimen of postoperative analgesia based on thoracic epidural block, non-steroidal anti-inflammatory drugs and rescue doses of morphine in PCA system. The side effects and complications including atelectasis, pneumonia, atrial fibrillation, urine retention, hypotension, respiratory depression and sedation will be analysed.

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
None

入排标准

性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) physical status 1-3
  • undergo videothoracoscopic lung lobectomy
  • forced expiratory volume in 1 second (FEV1) >1,5 l/min
  • no contraindications for epidural anesthesia
  • ability to comprehend principles of VAS pain examination method and to communicate in accordance with them.

排除标准

  • prior to the study: contraindications for local anesthesia, ASA>3, FEV1<1,5 l/min, conditions disabling the patient from comprehending the principles of VAS pain examination, known allergy to used medications.
  • during the study: failure to place epidural catheter, decision to abandon lobar resection (e.g. in case of neoplastic dissemination), intraoperative conversion to thoracotomy, intraoperative anatomical obstacles to distribution of local anesthetics, conditions disabling the patient from pain evaluation by means of VAS method (e.g. postoperative delirium), necessity to administer other pharmaceuticals influencing pain perception (e.g. sedatives), necessity of mechanical ventilation, interruption of local anesthesia as a result of technical problems (e.g. damage or slippage of catheter).

研究组 & 干预措施

uniportal VATS lobectomy

Experimental
  • uniportal VATS lobectomy
  • thoracic epidural block (0.125% bupivacaine with epinephrine 1:50000, continuous infusion 3-4 ml/hour)
  • ketoprofene 100 mg i.v every 12 hours
  • paracetamol 1000 mg i.v every 8 hours
  • rescue doses of morphine in PCA system (bolus dose 2 mg i.v)
  • pain intensity measured in VAS scale

干预措施: pain intensity measured in VAS scale (Diagnostic Test)

two-ports VATS lobectomy

Active Comparator
  • two-ports VATS lobectomy
  • thoracic epidural block (0.125% bupivacaine with epinephrine 1:50000, continuous infusion 3-4 ml/hour)
  • ketoprofene 100 mg i.v every 12 hours
  • paracetamol 1000 mg i.v every 8 hours
  • rescue doses of morphine in PCA system (bolus dose 2 mg i.v)
  • pain intensity measured in VAS scale

干预措施: pain intensity measured in VAS scale (Diagnostic Test)

three-ports VATS lobectomy

Active Comparator
  • three-ports VATS lobectomy
  • thoracic epidural block (0.125% bupivacaine with epinephrine 1:50000, continuous infusion 3-4 ml/hour)
  • ketoprofene 100 mg i.v every 12 hours
  • paracetamol 1000 mg i.v every 8 hours
  • rescue doses of morphine in PCA system (bolus dose 2 mg i.v)
  • pain intensity measured in VAS scale

干预措施: pain intensity measured in VAS scale (Diagnostic Test)

结局指标

主要结局

pain intensity

时间窗: up to 72 hours after the end of surgery

0-100 mm VAS scale measured every 4 hours on standard ruler beginning from the end of the surgery

次要结局

  • opioid consumption(up to 72 hours after the end of surgery)
  • rate of complications(up to 72 hours after the end of surgery)

研究者

发起方
Pulmonary Hospital Zakopane
申办方类型
Other
责任方
Sponsor

研究点 (2)

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