A phase 3 active-controlled trial of liposomal bupivacaine via sciatic nerve block in the popliteal fossa after bunionectomy
Authors' conclusion
LB 133 mg administered via sciatic nerve block in the popliteal fossa after bunionectomy demonstrated superior and long-lasting postsurgical pain control versus BUPI.
Study context
- Population
- Adults, ASA ≤3, BMI ≥18 to <40 kg/m², undergoing elective distal metaphyseal osteotomy (bunionectomy)parts A + B
- Participants
- 185 adults
- Comparison
- Liposomal bupivacaine (LB) 133 mg vs BUPI
- LB 266 mgn = 22
- Primary endpoint
- AUC of numerical rating scale (NRS) pain intensity scores
- Follow-up
- 0-96 h after surgery
Methodological detailstwo-part, double-blind, active-controlled, 6 sites
- Two-part
- Double-blind
- Active-controlled
- 6 sites
Primary result
As reported in the abstract
AUC of NRS pain intensity score · 0-96 h
LB 133 mg
207.4
least squares mean
BUPI
371.4
least squares mean
P < 0.00001
Secondary outcomes
| Outcome | LB 133 mg | BUPI | OR (95% CI) | P value | |
|---|---|---|---|---|---|
| Opioid-free participants · 0-96 hLB 133 mg vs BUPI · parts A + B | 24.4% | 6% | 5.04 (2.01–12.62) | P = 0.0003 | |
| 0.050.21520Odds ratio (log scale) |
| Outcome | LB 133 mg | BUPI | P value |
|---|---|---|---|
| Total opioid consumption · 0-96 hLB 133 mg vs BUPI · parts A + B | least squares mean 17.7 (95% CI 13.7–22.8) MMEs | least squares mean 45.3 (95% CI 35.1–58.5) MMEs | P < 0.00001 |
Safety
Adverse events
- Similar across groups
Original publication
A phase 3 active-controlled trial of liposomal bupivacaine via sciatic nerve block in the popliteal fossa after bunionectomy. J Clin Anesth. Published 9 February 2024. doi:10.
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