The Efficacy and Safety of Loxoprofen Sodium Patch in Relieving Postoperative Pain After Thoracoscopic Surgery

Официальное название

The Efficacy and Safety of Incisional Preemptive Analgesia Using Loxoprofen Sodium Patch in Patients Undergoing Thoracoscopic Surgery: a Multi-center Randomized Controlled Trial.

Обзор

Video-assisted thoracoscopic surgery (VATS) is less invasive compared to traditional thoracotomy, but it is still reported that the incidence of acute pain following VATS exceeds 80%. Inadequate postoperative analgesia may trigger a series of adverse physiological stress responses, increase the occurrence of postoperative complications, and affect the rehabilitation process. If acute pain is not managed promptly and sufficiently, nearly one-quarter of patients may develop chronic pain, impacting normal life and sleep quality after discharge. Acute pain after VATS is mainly caused by the release of inflammatory mediators after soft tissue injury at the surgical site, which activates peripheral pain receptors and leads to abnormal action potentials transmitted along A δ and C fibers. Inflammatory mediators released from the soft tissues around incisions not only significantly alters the chemical microenvironment at the peripheral terminals of nociceptors, directly inducing pain, but also sensitizes afferent fibers, contributing to peripheral sensitization. Therefore, drugs with potent local anti-inflammatory properties such as Loxoprofen Sodium may play a key role in preventing or reducing postoperative pain. The investigators conducted a multicenter, prospective, randomized controlled clinical study to explore the use of Loxoprofen Sodium Patch for preoperative local incision analgesia in VATS patients. The investigators aim to observe whether this method can effectively alleviate postoperative incision pain, reduce the dosage of postoperative analgesics and the side effects caused using postoperative analgesics, improve patient satisfaction, and provide new ideas for postoperative analgesia in VATS patients, promoting rapid recovery after VATS.

Вмешательства

• Препарат Loxoprofen Sodium Patch on the incision site
  Apply Loxoprofen Sodium Patch on the incision site of patients undergoing Video-assisted thoracoscopic surgery 12 hours before surgery
• Препарат Loxoprofen Sodium Patch on the contralateral side
  Apply Loxoprofen Sodium Patch on the contralateral side of patients undergoing Video-assisted thoracoscopic surgery 12 hours before surgery

Первичные конечные точки

• Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively [Срок оценки: The postoperative period 48 hours]

Вторичные конечные точки (8)

• Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively [Срок оценки: Data will be collected at 4、12、24、36 and 72 hours postoperatively]
• Area under the curve (AUC) of the Numerical Rating Scale during movement (NRSm) within 0-72 hours postoperatively [Срок оценки: Data will be collected at 4、12、24、36 and 72 hours postoperatively]
• Numeric Rating Scale at rest (NRSr) at 1 week, 1 month, and 3 months postoperatively [Срок оценки: Postoperative 7 day, 1 month and 3 month.]
• Patient Satisfaction Scale(PSS) [Срок оценки: Postoperative hours 4、12、24 and 48 hours]
• Postoperative nausea and vomiting(PONV) [Срок оценки: Postoperatively within 48 hours]
• wound healing score [Срок оценки: Postoperative 72 hours、1 and 3 months.]
• postoperatively and patient and observer scar assessment scale [Срок оценки: Postoperative 72 hours、1 and 3 months]
• Adverse events [Срок оценки: Within 72 hours postoperatively]

Критерии участия

Критерии включения

• Patients scheduled for elective Video-assisted thoracoscopic surgery for wedge resection, segmentectomy and lobectomy of the lungs under general anesthesia;
• 8 to 64 years old;
• American Society of Anesthesiologists (ASA) physical status of I-III;
• Patients must be able to understand the nature and potential personal consequences of the clinical trial and cooperate with follow-up investigations
• signing of the informed consent form.

Критерии исключения

• History of chronic pain syndrome of any cause and mental illness;
• Excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks or 3 days per week for more than 1 month), use of drugs with confirmed or suspected sedative or analgesic effects, or use of any painkiller within 24 h before surgery;
• History of hypertension (Grade 3, extremely high risk);
• Pregnancy or breastfeeding;
• Extreme body mass index (BMI) (< 15 or > 35);
• Participation in another interventional trial that interferes with the intervention or outcome of this trial;
• Digestive system diseases (such as peptic ulcers, gastric bleeding);
• Patients with coronary artery disease;
• Patients with renal impairment (serum creatinine > 176 µmol/L) and abnormal liver function(alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2× the upper limit of normal (ULN) or total bilirubin (TBIL) ≥ 1.5×ULN);
• Subjects with coagulation dysfunction (prothrombin time or activated partial thromboplastin time is higher than the normal threshold) or patients who are taking oral anticoagulants for other medical reasons and have not stopped it before surgery, such as warfarin or new anticoagulants rivaroxaban or dabigatran;
• Patients with a history of allergy to anyone of the study drugs;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07591220 · KY2025-338-02-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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