Pain, Postoperative / Acute Pain
Conditions
Brief summary
The purpose of this phase 2 study is to evaluate the efficacy and safety of PCA regimen of opiranserin (VVZ-149) injections in patients undergoing laparoscopic colectomy.
Interventions
VVZ-149 injections mixed with normal saline will be intravenously infused as a 180 mg loading dose over 30 minutes, starting from the initiation of surgical closure. After recovery from anesthesia, VVZ-149 injections will be administered via PCA (VVZ-149 10 mg in 2 mL, 10-min lock-out, basal infusion 6 mL/h)
DRUGFentanyl
VVZ-149 injections mixed with normal saline will be intravenously infused as a 180 mg loading dose over 30 minutes, starting from the initiation of surgical closure. After recovery from anesthesia, VVZ-149 injections + fentanyl will be administered (VVZ-149 injections 10 mg + fentanyl 4 μg in 2 mL, 10-min lock-out, basal infusion 6 mL/h)
Sponsors
Samsung Medical Center
Vivozon, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must have the ability to voluntarily provide written informed consent, understand study * Men and women subjects aged ≥19 years and \<75 years * Female subjects who are not pregnant or breastfeeding * Subjects must be undergoing a planned first laparoscopic colectomy * Subjects classified in American Society Anesthesiologist (ASA) risk class of I or II
Exclusion criteria
* Subjects undergoing emergency or unplanned surgery * Subjects who had a previous laparoscopic colectomy or resection procedure * Subjects with pre-existing conditions causing preoperative pain around the site of surgery * Female subjects who are pregnant or breastfeeding * Diagnosis of chronic pain (e.g., persistent pain with the intensity of NRS ≥ 5 at baseline)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the pain intensity-time curve over 8 hours (AUC 8) | 0-8 hours post-emergence | Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0 (no pain) to 10 (worst pain imaginable). The area under the curve of the pain intensity over time graph from 0 to 8 hours will be calculated using pain intensity measured at scheduled time points and pre-rescue medication time points, as well as imputed values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of PCA and rescue medication use and requests, and consumption measured at 2 hours for 12 hours post-emergence | 0-12 hours post-emergence | The total number of patient-controlled analgesia (PCA) requests and consumption from Time 0 to 12 hours was compared between the two groups. |
| Number of PCA and rescue medication use and requests, and consumption measured at 6 hours for 24 hours post-emergence | 0-12 hours post-emergence | Total amount of PCA and rescue medication consumption from Time 0 to Time 24 hours was compared between the two groups. |
Countries
South Korea
Outcome results
None listed