None listed
Conditions
Interventions
Drug : [VVZ-149 Treatment Group]
On Day 1 (-0.5h/1h/4h/7h), 180 mg of VVZ-149 was mixed with saline and administered by intravenous infusion over 30 minutes.
[Placebo Group]
On Day 1 (-0.5h/1h/4h/7h)
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women aged 19 years or older. 2. For women, not pregnant or breastfeeding. 3. Undergoing pre-planned colectomy surgery. 4. American Society of Anesthesiologist (ASA) risk class I or II. 5. Voluntarily sign an informed consent form before participating in the study, understand the purpose and procedures of the study, and are able to communicate clearly with the investigator.
Exclusion criteria
Exclusion criteria: 1. Emergency or Unplanned surgery 2. Reoperation for the same condition or reoperation for laparoscopic visceral resection. 3. Pain in the surgical site and surrounding area since before surgery. 4. Women who are pregnant or breastfeeding 5. Diagnosed with chronic pain (e.g., persistent pain of NRS 5 or greater at baseline) 6. Subjects 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. Electrocardiographic measurements 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. 10. History of alcohol, opiate, or other drug abuse or dependence within 12 months prior to screening (according to DSM-5 criteria). 11. Current or recent (within 30 days prior to surgery) use of opioids, antipsychotic medications. 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 before surgery 16. Use of medications known to increase PR or QRS interval (Appendix A) within 24 hours prior to surgery. 17. Use of inhibitors or inducers of CYP3A, or drugs that affect the metabolism of the renal transporters OCT2 and MATE1/2K (Appendix B) within 24 hours prior to surgery. 18. Use of nervous system medications or local anaesthetics (other than for anaesthetic purposes) in connection with surgery. 19. Use of parenterally administered ketamine (any dose), gabapentin, pregabalin, or lidocaine (>1 mg/kg) during or after surgery, or within 24 hours prior to surgery. 20. Known hypersensitivity to opioids. 21. Received any other investigational drug within 30 days prior to surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the pain intensity curve at 9 hours postoperatively (AUC 9) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain intensity reported at 0 hour upon awakening from anesthesia after surgery;Number of PCA requests and rescue medication requests and consumption amount measured at 2-hour intervals during 12 hours after surgery;Difference in pain intensity before and after administration of clinical trial drug after surgery | — |
Countries
Korea, Republic of
Contacts
Public ContactSang-Wook Lee
Asan Medical Center
Outcome results
None listed