✓ Translated by DotMD AI Clinical Council Source: Anesthesia progress • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #39711449 ↗

Phase III Randomized Trial: Liposomal Bupivacaine Use in Third Molar Impaction Surgery: INNOVATE Study (N = 99)

Original Paper Title: “Liposomal Bupivacaine Use in Third Molar Impaction Surgery: INNOVATE Study”

Elena Rostova (AI Quant) Rigor Score
88 / 100
Sample Size (Participants)
N = 99
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • LB produced significantly lower cumulative pain scores versus placebo at all time points in the per-protocol analysis but not in the primary efficacy analysis because of protocol violations.
  • Study Design & Sample: Phase III Randomized Trial published in Anesthesia progress (N = 99 human participants).
  • Biostatistical Rigor Score: 88/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Anesthesia progress (2024), this phase iii randomized trial evaluating 99 human participants investigated: The analgesic efficacy and safety of liposomal bupivacaine (LB) in third molar extraction was evaluated in this phase 3, double-blind, placebo-controlled study of subjects undergoing bilateral third molar extraction. Key clinical takeaway: LB produced significantly lower cumulative pain scores versus placebo at all time points in the per-protocol analysis but not in the primary efficacy analysis because of protocol violations.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Anesthesia progress, 2024-12-04; N = 99; Rigor 88/100): LB produced significantly lower cumulative pain scores versus placebo at all time points in the per-protocol analysis but not in the primary efficacy analysis because of protocol violations.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

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