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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorBeijing Tiantan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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

Treatment groups

134 Participants
are divided into 2 treatment groups
Group A: On the contralateral sideActive comparator 1 intervention
Group B: On the incision siteExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively

Time frame
The postoperative period 48 hours

Secondary outcomes

1

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
2

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
3

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.
4

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

Other outcomes

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