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Clinical Trials in China / NCT07591207
Recruiting Not applicable

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

NCT07591207 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Tiantan Hospital
Phase
Not applicable
Started
2026-06-01
Last updated
2026-06-16

Condition(s) studied

Loxoprofen Sodium PatchLocal IncisionLaparoscopic CholecystectomyAppendectomy, LaparoscopicHernia Repair

Investigational drug(s) / intervention(s)

Loxoprofen Sodium Patch on the contralateral sideLoxoprofen Sodium Patch on the incision site

Loxoprofen Sodium Patch on the contralateral side: Apply Loxoprofen Sodium Patch on the contralateral side of the incision in patients undergoing laparoscopic surgery 12 hours before surgery.

Loxoprofen Sodium Patch on the incision site: Apply Loxoprofen Sodium Patch on the incision site of patients undergoing laparoscopic surgery 12 hours before surgery

Study summary

Studies have shown that up to 80% of patients experience postoperative pain following laparoscopic surgery due to inflammation caused by surgical incisions and surrounding tissues, necessitating pharmacological relief. Inflammatory mediators released from the soft tissues around laparoscopic 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.

The investigators conducted a multicenter, prospective, randomized controlled clinical study to explore the use of Loxoprofen Sodium Patch for preoperative local incision analgesia in laparoscopic surgery 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 laparoscopic surgery patients, promoting rapid recovery after laparoscopic surgery.

Eligibility

Sex
ALL
Min age
18 Years
Max age
64 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients scheduled for elective Laparoscopic Surgery for laparoscopic cholecystectomy, appendectomy, or hernia repair under general anesthesia; 2. Ages 18 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. Exclusion Criteria: 1. 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. 3. 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). 10. 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. 11. Patients with a history of allergy to anyone of the study drugs.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Beijing Tiantan Hospital Beijing Beijing Municipality Not Yet Recruiting
Beijing Tiantan Hospital Beijing Beijing Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07591207 on ClinicalTrials.gov ↗ ← All trials in China