Phase 1 single-centre, placebo and levobupivacaine controlled study in healthy volunteers to assess the safety, tolerability, efficacy, and pharmacokinetics of LL10, a novel long-acting local anaesthetic
Authors' conclusion
The 1.26%/0.325% LL10 was tolerated in healthy volunteers at doses up to 40 ml (equivalent to 7/1.81 mg kg-1). LL10 produced prolonged local anaesthesia in FNB compared with levobupivacaine 0.325%, but not in s.c. infiltration or transversus abdominus plane block.
Study context
- Population
- Healthy volunteersenrolled
- Participants
- 137 volunteers
- Comparison
- LL10 vs Levobupivacaine vs Placebo
- Levobupivacainen = 18reference
- Placebon = 20
- Outcome
- Safety, tolerability, efficacy and pharmacokinetics of LL10
Methodological detailssingle-centre, placebo-controlled, levobupivacaine-controlled, concentration and volume escalation
- Single-centre
- Placebo-controlled
- Levobupivacaine-controlled
- Concentration and volume escalation
Main finding
As reported in the abstract
Severe AEs
- No severe adverse events (AEs) in any enrolled subject
Further findings
Median, h
| Outcome | LL10 | Levobupivacaine | P value |
|---|---|---|---|
| FNB duration, LL10 1.26%/0.325% vs levobupivacaine 0.325% | 25.0 (range 21.8–29.5) | 15.5 (range 6.0–21.2) | P = 0.021 |
Pharmacokinetics
- LL10 showed linear pharmacokinetics
Safety
Systemic AEs after transversus abdominis plane block (TAPB) (dizziness, perioral and tongue numbness, cardiovascular symptoms)
- Dose-dependent; all resolved spontaneously
Original publication
Phase 1 single-centre, placebo and levobupivacaine controlled study in healthy volunteers to assess the safety, tolerability, efficacy, and pharmacokinetics of LL10, a novel long-acting local anaesthetic. Br J Anaesth. Published 23 December 2025. doi:10.
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