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Htx-011 Reduced Pain Intensity And Opioid Consumption Versus Bupivacaine Hcl In Bunionectomy: Phase Iii Results From The Randomized Epoch 1 Study., Eugene R. Viscusi, Joseph S. Gimbel, Richard A. Pollack, Jia Hu, Gwo-Chin Lee

Department of Anesthesiology Faculty Papers

BACKGROUND AND OBJECTIVES: There is a need for local anesthetics that provide consistent analgesia through 72 hours after surgery. This study evaluates the use of HTX-011 (bupivacaine and meloxicam in Biochronomerpolymer technology), an extended-release, dual-acting local anesthetic, in reducing both postoperative pain over 72 hours and postoperative opioid use when compared with bupivacaine hydrochloride (HCl) and saline placebo. Inclusion of low-dose meloxicam in HTX-011 is designed to reduce local inflammation caused by surgery, potentiating the analgesic effect of bupivacaine. Previously, significant synergy has been observed with bupivacaine and meloxicam with both given locally together.

METHODS: EPOCH 1 was a randomized, …

Intravenous Meloxicam For The Treatment Of Moderate To Severe Acute Pain: A Pooled Analysis Of Safety And Opioid-Reducing Effects., Eugene R. Viscusi, Tong J. Gan, Sergio Bergese, Neil Singla, Randall J. Mack, Stewart W. Mccallum, Wei Du, Sue Hobson

Department of Anesthesiology Faculty Papers

BACKGROUND AND OBJECTIVES: To describe the safety and tolerability of intravenous meloxicam compared with placebo across all phase II/III clinical trials.

METHODS: Safety data and opioid use from subjects with moderate to severe postoperative pain who received ≥1 dose of intravenous meloxicam (5-60 mg) or placebo in 1 of 7 studies (4 phase II; 3 phase III) were pooled. Data from intravenous meloxicam 5 mg, 7.5 mg and 15 mg groups were combined (low-dose subset).

RESULTS: A total of 1426 adults (86.6% white; mean age: 45.8 years) received ≥1 dose of meloxicam IV; 517 (77.6% white; mean age: 46.7 years) …