Clinical utility of randomized controlled trials of regional anesthesia for lower-extremity surgery: a systematic review.

Abstract

Regional anesthesia (RA) is central to multimodal analgesia, yet many supporting randomized controlled trials (RCTs) may lack the rigor needed for evidence-based block selection. To evaluate the clinical usefulness and transparency of RCTs investigating RA interventions for lower extremity surgeries, using the van 't Hooft <i>et al</i> framework. Embase/MEDLINE were searched for RCTs (2014-2024) examining RA interventions for lower-extremity surgery. Data were extracted in duplicate using clinical-utility and transparency criteria. Analyses included descriptive statistics, linear regression for temporal trends, Pearson correlation, and multivariable regression to identify predictors of usefulness. Among 248 RCTs, patient-centeredness was universal, while feasibility (77.0%) and context placement (77.4%) were common. Pragmatism (2.0%) and value-for-money analyses (0%) were rare. Transparency varied: conflicts of interest were disclosed in 88.7%, pre-registration occurred in 39.9%, public protocols in 10.1%, and raw-data sharing in 1.2%. Transparency improved over time, correlated with clinical-utility scores (r=0.32, p<0.001) and was greater in hospital-funded, self-funded, and higher-impact journals. Usefulness scoring involves subjective judgment; non-English trials were excluded; the absence of formal risk of bias analysis limits interpretability of trial quality. Although transparency is improving, most trials remain insufficiently pragmatic, lack economic evaluation, and rarely share data, limiting real-world applicability. The results of this study suggest that aligning funder, journal, and collaborative expectations around open science and pragmatic design could accelerate the generation of high-utility evidence for perioperative block selection.