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

NCT07591207 | Not Yet Recruiting DMC

• 1 other identifier: KY2025-338-02-1
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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. We 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. 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 laparoscopic surgery patients, promoting rapid recovery after laparoscopic surgery.

Conditions

Laparoscopic Surgery; Loxoprofen Sodium Patch; Local Incision

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 day 7, month 1, and month 3.

• Patient Satisfaction Scale(PSS)

  Postoperative hours 4、12、24 and 48 hours

• Postoperative nausea and vomiting(PONV)

  Postoperatively within 48 hours

Study Arms (2)

On the contralateral side

ACTIVE COMPARATOR

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

On the incision site

EXPERIMENTAL

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

Interventions

Loxoprofen Sodium Patch on the contralateral side DRUG

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

On the contralateral side

Loxoprofen Sodium Patch on the incision site DRUG

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

On the incision site

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 Laparoscopic Surgery for laparoscopic cholecystectomy, appendectomy, or hernia repair under general anesthesia;
• Ages 18 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
• signing of the informed consent form.

You may not qualify if:

• 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.
• Extreme body mass index (BMI) (\< 15 or \> 35).
• Participation in another interventional trial that interferes with the intervention or outcome of this trial.
• Digestive system diseases (such as peptic ulcers, gastric bleeding).
• Patients with coronary artery disease.
• 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

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location

Related Publications (3)

• Fujiki EN, Netto NA, Kraychete DC, Daher MT, Tardini R, Nakamoto A, Lopes DG. Efficacy and safety of loxoprofen sodium topical patch for the treatment of pain in patients with minor acute traumatic limb injuries in Brazil: a randomized, double-blind, noninferiority trial. Pain. 2019 Jul;160(7):1606-1613. doi: 10.1097/j.pain.0000000000001549.

  PMID: 30839430 RESULT

• Lee IO, Kim SH, Kong MH, Lee MK, Kim NS, Choi YS, Lim SH. Pain after laparoscopic cholecystectomy: the effect and timing of incisional and intraperitoneal bupivacaine. Can J Anaesth. 2001 Jun;48(6):545-50. doi: 10.1007/BF03016830.

  PMID: 11444448 RESULT

• Bisgaard T, Klarskov B, Kristiansen VB, Callesen T, Schulze S, Kehlet H, Rosenberg J. Multi-regional local anesthetic infiltration during laparoscopic cholecystectomy in patients receiving prophylactic multi-modal analgesia: a randomized, double-blinded, placebo-controlled study. Anesth Analg. 1999 Oct;89(4):1017-24. doi: 10.1097/00000539-199910000-00036.

  PMID: 10512282 RESULT

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: May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)