A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a bupivacaine hydrochloride implant in patients undergoing abdominoplasty
Authors' conclusion
Compared with placebo, INL-001 provides postoperative analgesia that is temporally aligned with the period of maximal postsurgical pain in abdominoplasty and offers a favorable safety profile.
Study context
- Population
- Patients undergoing abdominoplasty
- Participants
- 181 vs 184
- Comparison
- Bupivacaine implant vs placebo collagen implants
- INL-001n = 181
- Placebon = 184reference
- Primary endpoint
- Sum of time-weighted pain intensity (SPI24)
- Follow-up
- 24 hours postsurgery
Methodological detailsdouble-blind, placebo-controlled, Follow-up up to 30 days, Opioids and acetaminophen allowed postoperatively; no other analgesics into surgical site
- Double-blind
- Placebo-controlled
- Follow-up up to 30 days
- Opioids and acetaminophen allowed postoperatively; no other analgesics into surgical site
Primary result
As reported in the abstract
SPI24 · 24 hours
| Group | Value | 95% CI |
|---|---|---|
| INL-001 | mean 102 (SD 43) | 95 to 109 |
| Placebo | mean 117 (SD 45) | 111 to 123 |
Value
INL-001mean 102 (SD 43)
Placebomean 117 (SD 45)
95% CI
INL-00195 to 109
Placebo111 to 123
- INL-001 vs Placebo: P = 0.002
Secondary outcomes
| Outcome | INL-001 | Placebo |
|---|---|---|
| SPI48 · 48 hoursMean | 190 (SD 88) | 206 (SD 96) |
| 95% CI | 177 to 204 | 192 to 219 |
| SPI72 · 72 hoursNot statistically significant (sequential testing) · mean | 265 (SD 131) | 281 (SD 146) |
| 95% CI | 244 to 285 | 261 to 301 |
| Opioid-free patients at 24, 48, 72 hoursNot statistically significant (sequential testing) | 19%, 17%, 17% | 6.5% |
- SPI48: sequential testing; subsequent secondary variables declared not statistically significant
- Opioid-free patients at 24, 48, 72 hours: placebo 6.5% at all timepoints
SPI48 · 48 hours
- Not significantly different between groups
Safety
Back pain (only AE in ≥5% with INL-001 > placebo)
Original publication
A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a bupivacaine hydrochloride implant in patients undergoing abdominoplasty. Reg Anesth Pain Med. Published 19 April 2023. doi:10.
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