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

Официальное название

The Efficacy and Safety of Incisional Preemptive Analgesia Using Loxoprofen Sodium Patch in Patients Undergoing Laparoscopic Surgery: a Multi-center Randomized Controlled Trial.

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively [Срок оценки: The postoperative period 48 hours]

Вторичные конечные точки (8)

• Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Postoperative day 7, month 1, and month 3.]
• Patient Satisfaction Scale(PSS) [Срок оценки: Postoperative hours 4、12、24 and 48 hours]
• Postoperative nausea and vomiting(PONV) [Срок оценки: Postoperatively within 48 hours]
• wound healing score [Срок оценки: Postoperative 72hours、1 and 3 months.]
• postoperatively and patient and observer scar assessment scale [Срок оценки: Postoperative 72 hours、1 and 3 months]
• Adverse events [Срок оценки: Within 72 hours postoperatively]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Китай · 2 центра

• Beijing Tiantan Hospital — Пекин
• Beijing Tiantan Hospital — Пекин

Публикации

• 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
• 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
• 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

Идентификаторы

NCT: NCT07591207 · KY2025-338-02-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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