What is it about?

While randomized controlled trials are considered the gold standard in clinical research, a crucial limitation is their lack of generalizability, partly due to strict eligibility criteria. With the ongoing opioid epidemic, this seems particularly true for regional anesthesia-related randomized controlled trials because preoperative opioid use is a commonly applied exclusion criterion. In this article, we will review the following: (1) the problems associated with restricting randomized controlled trials to opioid-naive populations and (2) possible solutions to improve recruitment and external validity

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Why is it important?

The recent designation of the opioid epidemic as a national public health emergency emphasizes its national health implications while also recognizing the challenges in research ahead. We highlight the problems and potential solutions to incorporating the opioid-tolerant population into regional anesthesia-related randomized controlled trials. Improving generalizability of study results to the opioid-tolerant cohort will assist clinicians in developing an evidence-based pain management approach for this difficult-to-treat population.

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This page is a summary of: To Include or Exclude? That Is the Question for Clinical Researchers Investigating in the Current Opioid Epidemic, Anesthesia & Analgesia, March 2019, Wolters Kluwer Health, DOI: 10.1213/ane.0000000000004090.
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