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

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 introduced to the clinical trial marketplace in 2014 to address the need for a viable soft-tissue model. Since then, at least 13 industry-sponsored studies, including multiple pivotal trials, have been conducted, providing a data set that can be used to interrogate the model's strengths and weaknesses. The authors outline the development history of abdominoplasty, discuss key clinical and design characteristics of the model, and review public data from abdominoplasty acute pain studies available to date. The data suggest that abdominoplasty is a well-validated soft-tissue surgical model that provides high-quality experimental outputs, enabling the efficacy of investigational analgesics in soft-tissue pain to be understood successfully.