None listed
Conditions
Interventions
Medical Device : Product is applied to all patients while suturing the incision site after the specified thoracoscopic surgery requiring a resection for a lung and esophageal disease and laparoscopic
Sponsors
Genewel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who signed or stamped on a written informed consent form for clinical trial participation 2. Subjects who are 19 years or older 3. Subjects who can participate during the duration of clinical trial 4. Subjects with no clinically significant abnormal findings from pre-operative laboratory tests 5. Subjects who are scheduled for incision surgery (incision length 3~6cm) 6. Subjects who can use patient-controlled analgesia (PCA)
Exclusion criteria
Exclusion criteria: 1. Subjects who were treated with any investigational product that may interfere with evaluation of safety and efficacy of this medical device or are in a treated medical condition 2. Patients with a hypersensitivity reaction to Ropivacaine or other Amide local anesthetics or such medical history 3. Patients with excessive bleeding or a shock state 4. Patients with inflammation on or around the injection site 5. Patients with sepsis 6. Intravenous partial anesthesia (Bier block anesthesia) 7. Paracervical block anesthesia in pregnant women, posterior ocular anesthesia, or spinal anesthesia (subarachnoid block anesthesia) is not used due to the lack of supporting evidence for use. Intravenous regional block (intravenous injection block anesthesia) is not used for insufficient clinical experience and the risk of blood toxicity. 8. Subjects who participated in other clinical trial within 30 days prior to clinical trial participation 9. Subjects who are determined by the investigator as ineligible (non-cooperation, etc.) 10. Pregnant women, subjects confirmed to be pregnant with a urine hCG test, or breastfeeding mothers 11. Subjects with a serious hepatic or renal disorder 12. Subjects with a serious psychiatric disorder 13. Patients on emergency surgery 14. Subjects who used drugs (narcotics, analgesics) continuously within the past 1 month 15. Subjects who have had surgery on the same site 16. Subjects with hypersensitivity or allergy to an Ag ingredient 17. Patients whose duration of operation exceeded 6 hr 18. Subjects with a thrombotic disorder or on antithrombotic therapy 19. Subjects who are pathologically obese (BMI =30 (BMI calculation: body weight (kg) / height (m)2)) 20. Subjects with a cardiac conduction disorder 21. Patients with a CNS disease 22. Patients with an apparent spinal defect 23. Subjects with a severe hypertension 24. Subjects with cardiovascular dysfunction such as a cardiac valve disorder 25. Subjects with a conduction disorder 26. Patients with acute porphyria 27. Subjects with a medical history of neuropathological symptoms (myasthenia gravis) 28. Subjects with difficulty in pain evaluation due to a neurological disease, etc. 29. Patients with a medical history of drug dependence or alcoholism 30. Patients with a hypersensitivity reaction to Fentanyl and Fentanyl ingredient or other opioids 31. Patients contraindicated for use of neuromuscular blockers 32. Patients with an organic disorder or injury of the head related with intracranial pressure elevation 33. Patients with a seizure disease or such medical history 34. Patients with asthma 35. Patients with severe respiratory suppression 36. Patients currently using MAO inhibitors or within 2 weeks after discontinuation of administration 37. Patients with a shooting pain of the gall bladder, pain after gall bladder surgery or acute alcoholism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Used amount of Fentanyl in PCA (up to post-operative 72 hr) | — |
Secondary
| Measure | Time frame |
|---|---|
| Used amount of rescue medication (up to post-operative 72 hr);Pain evaluation (up to post-operative 72 hr);Clinical tests, Adverse Events | — |
Countries
Korea, Republic of
Contacts
Public ContactYe Eun Choi
Genewel
Outcome results
None listed