The Efficacy and Safety of Incisional Preemptive Analgesia Using Loxoprofen Sodium Patch in Patients Undergoing Laparoscopic Surgery: a Multi-center Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 134
- 试验地点
- 2
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
On the contralateral side
We apply Loxoprofen Sodium Patch on the contralateral side of the incision in patients undergoing laparoscopic surgery 12 hours before surgery.
干预措施: Loxoprofen Sodium Patch on the contralateral side (Drug)
On the incision site
Apply Loxoprofen Sodium Patch to the incision site of patients undergoing laparoscopic surgery 12 hours before surgery
干预措施: Loxoprofen Sodium Patch on the incision site (Drug)
研究者
Fang Luo
Director, Department of Day Surgery, Principal
Beijing Tiantan Hospital