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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively | The postoperative period 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang Luo | Contact | +86 13611326978 | 13611326978@163.com |
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| 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 |
|
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. |
| 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 | 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. | Postoperative 7 day, 1 month and 3 month. |
| 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. | Postoperative hours 4、12、24 and 48 hours |
| Postoperative nausea and vomiting(PONV) | Postoperatively within 48 hours |
| wound healing score | The wound healing score is evaluated by independent researchers based on the wound healing score table, which includes three aspects: skin healing, incision infection, and hair growth. The total score is obtained by adding up the three scores. Excellent wound healing: 3 points; Good wound healing is 4-5; Poor wound healing: total score greater than or equal to 6 points. | Postoperative 72 hours、1 and 3 months. |
| postoperatively and patient and observer scar assessment scale | Postoperatively and patient and observer scar assessment scale: the observer scores the scar based on the distribution of blood vessels around the incision, color, scar thickness, surface roughness, area, and softness. Each score ranges from 1 to 10 points and higher scores indicating more severe scars; The patient evaluates the scar based on whether there is pain or itching, color, softness, thickness, and self-perception. Each score range is also 1-10 points, with 1 point indicating no difference from normal skin and a higher score indicating more severe scars. | Postoperative 72 hours、1 and 3 months |
| Adverse events | Such as itching, erythema, contact dermatitis, discomfort in the stomach, elevated ALT (GPT) and elevated AST (GOT) | Within 72 hours postoperatively |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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