Examination of clinical trials for post-operative, non-opioid pain management within the National Library of Medicine’s Clinical Trials Database

Abstract

Introduction/Objectives: Clinical trials are essential for the advancement of medical practice and patient care. In recent decades, opioids have been widely prescribed for managing post-operative pain, resulting in significant dependence and overuse. This study assesses recent clinical trials from the National Library of Medicine’s Clinical Trials database that utilize non-opioid treatment approaches for post-operative care.Design Methods: We searched for interventional trials registered at ClinicalTrials.gov from January 2009 through December 18, 2024. The trials were included in our analysis if they assessed only non-opioid post-operative pain management.Results: From the search of ClinicalTrials.gov, 52 trials were returned, from which 3 were excluded for being non-interventional and 2 were excluded for only including opioid treatments. Of the 47 trials included in the analysis, 22 (46.8%) were completed, 14 (29.8%) were active (or in enrolling or preenrolling stages), 7 (14.9%) were discontinued (suspended, terminated, or withdrawn) and 4 (8.5%) had unknown status. Among the completed trials, 21 (95.5%) used non-opioid drugs, while 1 (4.5%) used devices such as continuous local wound infusion (CLoWI). Of note, 11 (23.4%) of the 47 trials were specific to women, and 24 (51.0%) were conducted in the US.Discussion/Conclusion: Given the harms of opioid overuse, there is an urgent need for post-operative medical practices that reduce the risk of resultant dependence on these drugs. Our results showed that 47 non-opioid trials for post-operative pain have been registered since 2009. Among those trials, nearly half were conducted outside the United States, which is particularly noteworthy given the impact of the long-lasting opioid epidemic in the U.S. Additionally, nearly 1 in 4 trials were exclusive to females with the majority evaluating NSAIDS or local anesthetics as non-opioid alternatives for alleviating postoperative pain following cesarean section or gynecological surgery