An open-label, prospective, multicenter, active-control confirmatory clinical trial to evaluate the efficacy and safety in terms of the used amount of analgesics and pain relief effect of DDK gel mixed with a local anesthetic (Ropivacaine) for pain control applied to an incision site after thoracoscopic surgery requiring a resection for a lung and esophageal disease and laparoscopic surgery with a midline incisio

Not Applicable

Completed

• Conditions: Not Applicable

• Registration Number: KCT0006079
• Lead Sponsor: Genewel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-01-25
• Last Update Posted: 22 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 152

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

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified