Liposomal Bupivacaine Use in Third Molar Impaction Surgery: INNOVATE Study

Area of Science:

• Oral and Maxillofacial Surgery
• Anesthesiology
• Pharmacology

Background:

• Third molar extraction is a common surgical procedure often associated with significant postoperative pain.
• Effective pain management is crucial for patient recovery and satisfaction following third molar surgery.
• Liposomal bupivacaine (LB) is a long-acting local anesthetic that may offer prolonged analgesia.

Purpose of the Study:

• To evaluate the analgesic efficacy and safety of liposomal bupivacaine (LB) compared to placebo in patients undergoing bilateral third molar extraction.
• To assess pain severity using the Numeric Rating Scale (NRS) over a 96-hour period post-surgery.
• To determine the incidence of adverse events associated with LB in this patient population.

Main Methods:

• Phase 3, double-blind, placebo-controlled study involving subjects undergoing bilateral third molar extraction.
• Randomization of subjects to receive either liposomal bupivacaine (133 mg/10 mL) or placebo via infiltration.
• Pain severity assessed using the Numeric Rating Scale (NRS), with cumulative area under the curve (AUC) as the primary efficacy measure (AUC of NRS0-48).

Main Results:

• In the per-protocol population, liposomal bupivacaine demonstrated significantly lower cumulative pain scores (AUC of NRS0-48) compared to placebo (120.8 vs 183.3, P = .023).
• However, in the primary efficacy population, the difference in AUC of NRS0-48 between LB and placebo was not statistically significant (172.3 vs 194.7, P = .227).
• The safety profile was similar between the liposomal bupivacaine and placebo groups, with no significant differences in adverse events.

Conclusions:

• Liposomal bupivacaine demonstrated significant pain reduction in the per-protocol analysis for third molar extraction.
• Extensive protocol violations in the primary efficacy analysis precluded definitive conclusions regarding effectiveness.
• Further studies are warranted to confirm the analgesic efficacy of liposomal bupivacaine in this surgical model due to observed protocol deviations.