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临床试验/NCT02751619
NCT02751619已完成不适用

Preventive Application Of Lidocaine Patch In Adjunction To Intravenous Morphine Analgesia For Management Of Post-Thoracotomy Pain: Results Of A Randomized, Double Blind, Placebo Controlled Study

University of Campania "Luigi Vanvitelli"0 个研究点目标入组 90 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
90
主要终点
Changes in Pain Score measured with Visual Analogue Scale at rest and after coughing

研究概览

简要总结

Thoracotomy is one of the most painful surgical incision. Uncontrolled acute post-thoracotomy pain reducing deep breathing exercises and secretion clearance increased the incidence of postoperative pulmonary complications including atelectasis, hypoxemia, and postoperative pulmonary infections. Thus, an effective analgesia is crucial in order to reduce perioperative morbidity and hospitalization time and also to prevent chronic post-thoracotomy pain.

Thoracic epidural analgesia and thoracic paravertebral analgesia are currently the standard strategies for thoracic surgery but the difficult of performing them in all patients and their potential complications are all factors that limit their use. Systemic administration of opioids is the simplest and common strategy to provide analgesia but it may be associated with several undesirable effects, such as respiratory depression, sedation, nausea, constipation and vomiting.

In the recent years, preventive analgesia is become one of the most promising strategy of postoperative pain control. It is based on the concept of administering analgesic drugs before the occurrence of nociceptive input in order to prevent central sensitization. The efficacy of preemptive analgesia is unclear and there is no a consensus on its efficacy on controlling pain after thoracic procedure.

Pain following thoracotomy has a multifactorial genesis including surgical incision, intercostal nerve injury, pleural inflammation, and damage of pulmonary parenchyma and of diaphragm. Thus, a multimodal analgesia that intercepts the signalizing at numerous locations could be more effective than a single strategy targeting one site along the pain pathway.

Thus, in the present study, the clinical hypothesis was that the preemptive analgesia of the skin using a new tool as the Lidocaine patch 5% would improve the analgesic effects of systemic morphine analgesia for controlling post-operative pain following thoracotomy.

详细描述

This was an unicenter, double-blinded, placebo controlled, parallel-group, prospective study conducted at Thoracic Surgery Unit and Anesthesia and Intensive Care Unit of Second University of Naples from January 2013 to May 2015.

All consecutive patients undergoing undergoing anatomical resection by standard lateral thoracotomy for treatment of non small cell lung cancer (NSCLC) were randomly assigned to Lidocaine or Placebo group in 1:1 ratio and no changes to methods after trial commencement as type of randomization or eligibility criteria were attended.

For patients assigned to active group, Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc, Malvern, PA, USA) measuring 10 x 14 cm and containing 700 mg of Lidocaine, was applied to cover the planned skin incision, marked with a pen by surgeon. Patch was applied for 12 hours during the night, removed for the subsequent 12 hours during the day, and then a new patch was applied at the same level the night after. This process was continued for 3 days before thoracotomy. In the control group, a placebo patch, that was identical in appearance to the active patch but did not contain Lidocaine, was applied in the same manner for the same time. The pain service, surgical team, and patients were all blinded to treatment group assigned.

All patients received the same anesthetic protocol. All operations were performed in the early morning just after that the patch was removed. The general anesthesia was inducted with i.v. midazolam 0.05 mg/kg, i.v. fentanyl 1-1.4 µg/Kg, i.v. propofol 2.5 mg/kg, i.v. and rocuronium bromide 0.6 mg/kg. The patient was maintained with desflurane 4-6%, sulfentanil 0.5-1 micro/Kg, rocuronium bromide 0.6-0.8 mg/Kg, based on heart rate and blood pressure stability. A selective ventilation was performed with a double-lumen endobronchial tube in all cases and no additional analgesics were injected during surgery.

All patients had the same length of skin incision and a standard muscle-sparing lateral thoracotomy. The latissimus dorsi muscle and the underlying serratus anterior muscle were spared and the chest was entered over the top of the unresected and unshingled sixth rib. A standard Finocchietto chest retractor was then placed and slowly opened to avoid rib fracture. After completion of the appropriate anatomical lung resection, a single 28 F chest drainage was systematically placed in pleural cavity. The same chest closure was performed in all patients in a standard manner using intracostal sutures.

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, Investigator)

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

  • More than 18 years old
  • Anatomical resection by standard lateral thoracotomy for treatment of non small cell lung cancer

排除标准

  • Allergy to Lidocaine
  • American Society of Anaesthesiologist (ASA) classification score more than 3
  • History of previous thoracic surgical procedures and/or of chronic pain or taking regular analgesics
  • Pneumonectomy or concomitant decortication and/or chest wall injury or resection,
  • Psychiatric illness
  • Participation to other studies

研究组 & 干预措施

Lidocaine Group

Experimental

Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc, Malvern, PA, USA) measuring 10 x 14 cm and containing 700 mg of Lidocaine, was applied to cover the planned skin incision, marked with a pen by surgeon. Patch was applied for 12 hours during the night, removed for the subsequent 12 hours during the day, and then a new patch was applied at the same level the night after. This process was continued for 3 days before thoracotomy

干预措施: Lidocaine patch 5% (Drug)

Placebo Patch

Active Comparator

A patch, that was identical in appearance to the active patch but did not contain Lidocaine, was applied to cover the planned skin incision, marked with a pen by surgeon. Patch was applied for 12 hours during the night, removed for the subsequent 12 hours during the day, and then a new patch was applied at the same level the night after. This process was continued for 3 days before thoracotomy

干预措施: Placebo patch (Drug)

结局指标

主要结局

Changes in Pain Score measured with Visual Analogue Scale at rest and after coughing

时间窗: Post-operative follow-up-points: 6 hours, 12 hours , 24 hours , 36 hours, 48 hours and 72 hours

10-score Visual Analogue Scale (VAS) ranging from 0=absence of pain to 10= maximal level of pain

次要结局

  • Flow Expiratory Volume in one second (FEV1%)(Post-operative follow-up: 72 hours; 96 hours; 120 hours)
  • The frequency for hour of activation of PCA Device(Post-operative follow-up: 6 hours; 6-12 hours; 12- 24 hours; 24-36 hours, and 36-48 hours.)
  • Morphine consumption(Post-operative follow-up: 6 hours; 6-12 hours; 12- 24 hours; 24-36 hours, and 36-48 hours.)
  • Forced Vital Capacity (FVC%)(Post-operative follow-up: 72 hours; 96 hours; 120 hours)
  • Laser Evoked Potential Tests.(Follow-up: 1 month, 3 months, and 6 months after operation)

研究者

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

Alfonso Fiorelli

MD, PhD

University of Campania "Luigi Vanvitelli"

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