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

Official title

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

Overview

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.

Interventions

• Drug 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
• Drug 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

Primary outcome measures

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

Secondary outcome measures (8)

• Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively [Time frame: 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 [Time frame: 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 [Time frame: Postoperative 7 day, 1 month and 3 month.]
• Patient Satisfaction Scale(PSS) [Time frame: Postoperative hours 4、12、24 and 48 hours]
• Postoperative nausea and vomiting(PONV) [Time frame: Postoperatively within 48 hours]
• wound healing score [Time frame: Postoperative 72 hours、1 and 3 months.]
• postoperatively and patient and observer scar assessment scale [Time frame: Postoperative 72 hours、1 and 3 months]
• Adverse events [Time frame: Within 72 hours postoperatively]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07591220 · KY2025-338-02-2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗