About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Loxoprofen Sodium Patch on the incision site
DrugApply Loxoprofen Sodium Patch on the incision site of patients undergoing Video-assisted thoracoscopic surgery 12 hours before surgery
Loxoprofen Sodium Patch on the contralateral side
DrugApply Loxoprofen Sodium Patch on the contralateral side of patients undergoing Video-assisted thoracoscopic surgery 12 hours before surgery
Treatment groups
Trial outcomes
Primary outcomes
Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively
Secondary outcomes
Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively
scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain
Area under the curve (AUC) of the Numerical Rating Scale during movement (NRSm) within 0-72 hours postoperatively
The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain, scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain.
Numeric Rating Scale at rest (NRSr) at 1 week, 1 month, and 3 months postoperatively
The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain; scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain.
Patient Satisfaction Scale(PSS)
Patient Satisfaction Scale(PSS) on a scale ranging from 0 to 10, where 0 denotes "completely dissatisfied" and 10 signifies "extremely satisfied.
Locations
Sponsors and contacts
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