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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| On the incision site | Experimental | Apply Loxoprofen Sodium Patch to the incision site of patients undergoing laparoscopic surgery 12 hours before surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively | The postoperative period 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang Luo | Contact | +86 13611326978 | 13611326978@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100070 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30839430 | Result | 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. | |
| 11444448 |
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| 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 |
|
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. |
| 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. | 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." | Postoperative hours 4、12、24 and 48 hours |
| Postoperative nausea and vomiting(PONV) | 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. | 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. | 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) | Within 72 hours postoperatively |
| Beijing Tiantan Hospital | Recruiting | Beijing | Beijing Municipality | 100070 | China |
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| 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. |
| 10512282 | 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. |