An interventional study of Loxoprofen Sodium Patch on the contralateral side and Loxoprofen Sodium Patch on the incision site in Loxoprofen Sodium Patch, Local Incision and Laparoscopic Cholecystectomy, sponsored by Beijing Tiantan Hospital. Recruiting at 2 sites in China. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Prevention
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.
Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
We apply Loxoprofen Sodium Patch on the contralateral side of the incision in patients undergoing laparoscopic surgery 12 hours before surgery.
Drug: Loxoprofen Sodium Patch on the contralateral side
Apply Loxoprofen Sodium Patch to the incision site of patients undergoing laparoscopic surgery 12 hours before surgery
Drug: Loxoprofen Sodium Patch on the incision site
Apply Loxoprofen Sodium Patch on the contralateral side of the incision in patients undergoing laparoscopic surgery 12 hours before surgery.
Also known as: Active Comparator
Apply Loxoprofen Sodium Patch on the incision site of patients undergoing laparoscopic surgery 12 hours before surgery
Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively
Time frame: The postoperative period 48 hours
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
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
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 day 7, month 1, and month 3.
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
Postoperative nausea and vomiting(PONV)
Time frame: 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.
Time frame: Postoperative 72hours、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.
Time frame: 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)
Time frame: Within 72 hours postoperatively
Plan to share: Yes
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Beijing Tiantan Hospital