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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorBeijing Tiantan Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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 contralateral side

    Drug

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

Treatment groups

156 Participants
are divided into 2 treatment groups
Group A: Loxoprofen Sodium Patch on the contralateral sideActive comparator 1 intervention
Group B: Loxoprofen Sodium Patch on the incision siteExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively

Time frame
The postoperative period 48 hours

Secondary outcomes

1

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

Time frame
Data will be collected at 4、12、24、36 and 72 hours postoperatively
2

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.

Time frame
Data will be collected at 4、12、24、36 and 72 hours postoperatively
3

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.

Time frame
Postoperative 7 day, 1 month and 3 month.
4

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.

Time frame
Postoperative hours 4、12、24 and 48 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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