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

N/ANot Yet RecruitingNCT07591207

Beijing Tiantan Hospital134 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

134

Conditions

Loxoprofen Sodium Patch Local Incision

Interventions

Loxoprofen Sodium Patch on the contralateral sideDRUG

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 siteDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively

Time frame: The postoperative period 48 hours

Secondary Outcomes

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