None listed
Conditions
Interventions
Drug : Load Dose Administration: At the time of incision closure, 18 mL of VVZ-149 injection (VVZ-149 180 mg, load dose) is mixed in 100 mL of normal saline and administered as an intravenous drip ove
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria are eligible to participate in the study 1. voluntarily sign an informed consent form prior to participation in the study, understand the purpose and procedures of the study, and are able to communicate clearly with the investigator 2. males and females between 19 and 75 years of age 3. if female, not pregnant or lactating 4. undergoing pre-planned laparoscopic colectomy surgery 5. American Society of Anesthesiologist (ASA) risk class I or II
Exclusion criteria
Exclusion criteria: Subjects with any of the following criteria will be excluded from the study. [surgical factors]. 1. emergency or unplanned surgery 2. reoperation for the same condition or reoperation for laparoscopic viscerectomy 3. pain in the surgical site and surrounding area since before surgery [Subject's characteristics]. 4. Women who are pregnant or breastfeeding 5. Diagnosed with chronic pain (e.g., persistent pain of NRS 5 or greater at baseline) 6. Those with unstable or poorly controlled psychiatric illness (e.g., post-traumatic stress disorder [PTSD], anxiety disorder, depression). However, subjects on stable doses of antidepressants and anti-anxiety medications for at least 60 days prior to screening or subjects on surgery-related anti-anxiety medications will be eligible. 7. Subjects with unstable medical conditions (e.g., unstable angina pectoris, congestive heart failure, renal failure, hepatic insufficiency, acquired immunodeficiency syndrome). 8. Subjects with an electrocardiogram measurement of QRS >200 msec or QTcF >450 msec (men) or QTcF >470 msec (women) at screening and preoperative evaluation. 9. Body weight less than 50 kg. [Drug, alcohol, and pharmacological considerations]. 10. History of alcohol, opiate, or other drug abuse or dependence within 12 months prior to screening. 11. Current or recent (within 24 hours prior to surgery) use of opioids, antipsychotic medication 12. History of opioid tolerance based on questionnaire or clinician judgement. 13. Consumption of alcohol within 24 hours prior to surgery. 14. Use of non-narcotic analgesics or non-steroidal anti-inflammatory drugs (NSAIDs) (including COX-2 inhibitors) within 24 hours prior to surgery. 15. use of herbal preparations or nutraceuticals (chaparral, comfrey, germander, jin bu huan, kava, pennyroyal, skullcap, St. John's wort, valerian, etc.) within 7 days prior to surgery 16. Use of medications known to increase PR or QRS interval (Appendix A) within 24 hours prior to surgery. * Appendix A. Medications Known to Increase PR or QRS Interval - PR Interval Prolongation: Digoxin (Digitek®, Lanoxin®), Donepezil (Aricept®), Naratriptan (Amerge®), Propranolol (Atenolol®, Metoprolol®), Sumatriptan (Imitrex®), Verapamil (®) - QRS Interval Prolongation: Amiodarone, Amitriptyline, Amodiaquine, Amoxapine, Bupivacaine, Bupropion, Carbamazepine, Chloroquine (Aralen®), Citalopram, Desethylamodiaquine, Desipramine, Diltiazem, Diphenhydramine, Dolasetron, Fluoxetine, Imipramine, Lamotrigine, Maprotiline, Mesoridazine, Nortriptyline, Perhexiline, Procaine, Quetiapine (Seroquel®), Quinine, Risperidone, Ropivacaine, Thioridazine, Venlafaxine 17. Use of inhibitors or inducers of CYP3A, or drugs that affect the metabolism of renal transporters OCT2 and MATE1/2K (Appendix B) within 24 hours prior to surgery. * Appendix B. CYP3A Inhibitors or Inducers, Drugs Metabolised by OCT2 and MATE1/2 - CYP3A Inhibitors(Weak): chlorzoxazone, cilostazol, fosaprepitant, istradefylline, ivacaftor, lomitapide, ranitidine, ranolazine, tacrolimus, ticagrelor - CYP3A Inhibitors(Moderate): aprepitant, cimetidine, ciprofloxacin, clotrimazole, crizotinib, cyclosporine, dronedarone, erythromycin, fluconazole, fluvoxamine, imatinib, tofisopam, verapamil - CYP3A Inhibitors(Strong): boceprevir, cobicistat, conivaptan, danoprevir and ritonavir, elvitegravir and ritonavir, grapefruit juice, indinavir and ritonavir, itraconazole, ketoconazole, lopinavir and ritonavir, paritaprevir and ritonavir and (omb
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the pain intensity curve at 8 hours postoperatively (AUC 8);Safety assessment of VVZ-149 injection administered via patient-controlled analgesia (PCA) | — |
Secondary
| Measure | Time frame |
|---|---|
| PCA and rescue medication use and requests measured every 2 hours for 12 hours post-op;PCA and rescue medication use and requests measured at 6-hour intervals for 24 hours post-op | — |
Countries
Korea, Republic of
Contacts
Public ContactJEAYOUN KIM
Samsung Medical Center
Outcome results
None listed