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

NCT07591220 | Not Yet Recruiting DMC

• 1 other identifier: KY2025-338-02-2
• Study Type: interventional
• Target: 156
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. We conducted a multicenter, prospective, randomized controlled clinical study to explore the use of Loxoprofen Sodium Patch for preoperative local incision analgesia in VATS patients. We 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.

Conditions

Local Incision; Postoperative Pain; Video-assisted Thoracoscopic Surgery (VATS); Loxoprofen Sodium Patch

Outcome Measures

Primary Outcomes (1)

• Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively

  The postoperative period 48 hours

Secondary Outcomes (7)

• Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively

  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

  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

  Postoperative 7 day, 1 month and 3 month.

• Patient Satisfaction Scale(PSS)

  Postoperative hours 4、12、24 and 48 hours

• Postoperative nausea and vomiting(PONV)

  Postoperatively within 48 hours

Study Arms (2)

Loxoprofen Sodium Patch on the contralateral side

ACTIVE COMPARATOR

We apply Loxoprofen Sodium Patch on the contralateral side of the incision in patients undergoing Video-assisted thoracoscopic surgery 12 hours before surgery.

Drug: Loxoprofen Sodium Patch on the contralateral side

Loxoprofen Sodium Patch on the incision site

EXPERIMENTAL

Apply Loxoprofen Sodium Patch to the incision site of patients undergoing Video-assisted thoracoscopic surgery 12 hours before surgery

Drug: Loxoprofen Sodium Patch on the incision site

Interventions

Loxoprofen Sodium Patch on the incision site DRUG

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

Loxoprofen Sodium Patch on the incision site

Loxoprofen Sodium Patch on the contralateral side DRUG

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

Loxoprofen Sodium Patch on the contralateral side

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Patients scheduled for elective Video-assisted thoracoscopic surgery for wedge resection, segmentectomy and lobectomy of the lungs under general anesthesia; 2. 8 to 64 years old 3. American Society of Anesthesiologists (ASA) physical status of I-III 4. Patients must be able to understand the nature and potential personal consequences of the clinical trial and cooperate with follow-up investigations 5.signing of the informed consent form.

You may not qualify if:

• \. History of chronic pain syndrome of any cause and mental illness 2. 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) 4. Pregnancy or breastfeeding. 5. Extreme body mass index (BMI) (\< 15 or \> 35). 6. Participation in another interventional trial that interferes with the intervention or outcome of this trial. 7. Digestive system diseases (such as peptic ulcers, gastric bleeding). 8. Patients with coronary artery disease. 9. 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Fang Luo

CONTACT

+86 13611326978; 13611326978@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Day Surgery, Principal

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: May 15, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL