Efficacy and Safety Study of Postsurgical Analgesia With INL-001 in Abdominoplasty

Summary

This is a multicenter, randomized, double-blind, placebo-controlled efficacy and safety study of the INL-001 (bupivacaine HCl) implant, at 300 mg, in patients following abdominoplasty to evaluate postoperative analgesia.

Timeline

Start

2021-04-29

Primary completion

2021-10-27

Completion

2021-10-27

Publications

• Beaton AC, Solanki D, Salazar H, Folkerth S, Singla N, Minkowitz HS, Leiman D, Vaughn B, Skuban N, Niebler G. A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a bupivacaine hydrochloride implant in patients undergoing abdominoplasty. Reg Anesth Pain Med. 2023 Dec;48(12):601-607. doi: 10.1136/rapm-2022-104110. Epub 2023 Apr 19.

Drugs

Indications