None listed
Conditions
Interventions
Medical Device : In patients eligible for laparoscopic colorectal cancer surgery, Voferon mixed with the local anesthetic 0.75% ropivacaine hydrochloride (22.5 mg) was applied to the incision site aft
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 19 years or older scheduled for laparoscopic colorectal cancer surgery, including robotic procedures 2. Patients classified as American Society of Anesthesiologists Physical Status (ASA-PS) 1-2 and appropriate for general anesthesia 3. Patients who voluntarily decide to participate in this clinical trial, and the patient or their legal representative has signed and dated the informed consent form 4. Patients who understand and agree to comply with all scheduled visit requirements 5. Patients with no clinically significant abnormal findings on preoperative laboratory tests 6. Patients who are able to use patient-controlled analgesia (PCA)
Exclusion criteria
Exclusion criteria: 1. Individuals with a history of severe psychiatric disorders such as major depression. 2. Individuals who are receiving or have received investigational products, or who have medical conditions that may interfere with the evaluation of the safety and efficacy of the investigational device. 3. Patients with known hypersensitivity or a history of allergic reactions to ropivacaine or other amide-type local anesthetics. 4. Individuals with a history of serious adverse events following the administration of local anesthetics. 5. Individuals with clinically significant hepatic, gastrointestinal, renal, hematologic, urologic, neurologic, respiratory, endocrine, or cardiovascular disorders. 6. Individuals with specific electrocardiographic conduction abnormalities (e.g., Mobitz type II atrioventricular block, complete AV block). 7. Individuals with congenital long QT syndrome or a family history of the condition. 8. Individuals with a history of renal impairment, chronic respiratory disease, rheumatoid arthritis, or bleeding disorders. 9. Individuals with chronic neuromuscular deficits that may affect surgical outcomes. 10. Individuals with a body mass index (BMI) = 30 kg/m². 11. Individuals with a history of hypersensitivity, severe allergic reactions, or known allergies to hyaluronic acid. 12. Individuals with a history of drug or alcohol abuse. 13. Individuals with known hypersensitivity to fentanyl, fentanyl derivatives, or other opioid analgesics. 14. Individuals requiring surgical procedures in addition to colorectal or rectal cancer surgery. 15. Individuals experiencing massive bleeding or in a state of shock. 16. Individuals with inflammation at or around the injection site. 17. Individuals diagnosed with sepsis. 18. Individuals requiring intravenous regional anesthesia (Bier block). 19. Individuals requiring paracervical block, retrobulbar block, spinal (subarachnoid) anesthesia, or intravenous regional block. 20. Individuals with chronic kidney disease stage 4 or higher, or chronic liver disease with Child-Pugh class C. 21. Individuals with central nervous system (CNS) disorders. 22. Individuals with coagulation disorders. 23. Individuals with known spinal defects. 24. Individuals with severe cardiovascular dysfunction, such as uncontrolled hypertension or significant valvular heart disease. 25. Individuals with a history of neuropathic conditions such as myasthenia gravis. 26. Individuals with acute porphyria. 27. Individuals with a high risk of conversion to open abdominal surgery. 28. Individuals who have participated in another clinical trial (excluding observational studies) within 30 days prior to screening. 29. Pregnant or breastfeeding individuals. 30. Individuals who, in the opinion of the investigator or study personnel, are deemed unsuitable for participation in the study due to other clinically significant findings (e.g., uncooperative behavior).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative fentanyl consumption at 72 ± 6 hours postoperatively | — |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative fentanyl consumption at 4 ± 2 hours, 24 ± 6 hours, 48 ± 6 hours postoperatively;Cumulative rescue drug consumption at 4 ± 2 hours, 24 ± 6 hours, 48 ± 6 hours postoperatively;Numeric Rating Scale (NRS) for pain assessed at 4±2 hours, 24±6 hours, 48±6 hours, and 72±6 hours postoperatively | — |
Countries
Korea, Republic of
Contacts
Public ContactJung-woo Shim
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed