Abdominoplasty as an acute postoperative pain model: insights from 8 years of clinical trials.

ABSTRACT:

Abstract

To have a complete understanding of an experimental analgesic's efficacy in treating acute postoperative pain, it is necessary to understand its effect on both hard-tissue pain and soft-tissue pain. For this reason, regulatory bodies including the U.S. Food and Drug Administration and European EMA typically require drug developers to demonstrate efficacy in both hard-tissue and soft-tissue pain to grant a broad approval for an analgesic in acute postoperative pain. Hard-tissue models such as bunionectomy and molar extraction are well-validated and efficient with long histories in clinical trials, but until recently, a similarly well-standardized and fast-enrolling soft-tissue model was not available. Abdominoplasty was developed as an acute postoperative pain model and int

SUBMITTER: Singla N 

PROVIDER: S-EPMC9833108 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature