Evaluation of Preoperative N1539 in Total Knee Arthroplasty

Phase 3 Completed 194 enrolled Baudax Bio

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of this study is to assess the effect of preoperative administration of N1539 on opioid consumption in subjects undergoing open unilateral total knee arthroplasty compared to placebo.

Timeline

Start: 2018-02-19
Primary completion: 2019-05-21
Completion: 2019-05-21

Outcome

Met primary endpoint

paper Meloxicam IV was associated with less opioid use versus placebo during the 24 hours after surgery (18.9 ± 1.32 vs 27.7 ± 1.37 mg IV morphine equivalent dose; P < 0.001) PMID 33502533 ↗

Publications

Berkowitz RD, Steinfeld R, Sah AP, Mack RJ, McCallum SW, Du W, Black LK, Freyer A, Coyle E. Safety and Efficacy of Perioperative Intravenous Meloxicam for Moderate-to-Severe Pain Management in Total Knee Arthroplasty: A Randomized Clinical Trial. Pain Med. 2021 Jun 4;22(6):1261-1271. doi: 10.1093/pm/pnab016.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Meloxicam	Small molecule	30 mg	Intravenous

Indications

No indication recorded.