Reduction of postoperative pain and opioid consumption by VVZ-149, first-in-class analgesic molecule: A confirmatory phase 3 trial of laparoscopic colectomy
Authors' conclusion
When compared to placebo, VVZ-149 infusion demonstrated a significant reduction of pain within the first 12 h after surgery with a substantial decrease in opioid use.
Study context
- Population
- Patients undergoing laparoscopic colectomy with moderate to severe postoperative pain, South Korea
- Participants
- 284 patients
- Comparison
- VVZ-149 vs Placebo
- VVZ-149n = 141
- Placebon = 143reference
- Primary endpoint
- Sum of Pain Intensity Difference (SPID), pain by NRS
- Follow-up
- First 12 h after start of infusion
Methodological detailsparallel group, double-blind, phase 3, multicentre (5 tertiary referral centers), 5 tertiary referral centers in South Korea
- Parallel group
- Double-blind
- Phase 3
- Multicentre (5 tertiary referral centers)
- 5 tertiary referral centers in South Korea
Primary result
As reported in the abstract
SPID · 12 h
- VVZ-149 vs Placebo: P = 0.0047
Further findings
| Outcome | P value |
|---|---|
| SPID · 6 hPain relief significantly improved by 35 % | P = 0.0193 |
| Pain intensity scores (NRS) · 4-10 hSignificantly lower with VVZ-149 | P = 0.0007 |
| Rescue opioid-free patients · 2-6 h and 6-12 hVVZ-149 vs Placebo · higher proportion with VVZ-149, 2-6 h | P = 0.0026 |
| Rescue opioid-free patients · 2-6 h and 6-12 hVVZ-149 vs Placebo · higher proportion with VVZ-149, 6-12 h | P = 0.0024 |
Pain intensity scores (numeric rating scale (NRS)) · 4-10 h
- Mild pain (mean NRS <4) reached at 8 h with VVZ-149
Opioid consumption and patient-controlled analgesia (PCA) requests · first 12 h post-dose
%
- Less opioid consumption with VVZ-149 vs placebo
- 30.8
- Fewer PCA requests with VVZ-149 vs placebo
- 60.2
Original publication
Reduction of postoperative pain and opioid consumption by VVZ-149, first-in-class analgesic molecule: A confirmatory phase 3 trial of laparoscopic colectomy. J Clin Anesth. Published 19 December 2024. doi:10.
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