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

BACKGROUND

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.

OBJECTIVES

To evaluate the clinical usefulness and transparency of RCTs investigating RA interventions for lower extremity surgeries, using the van 't Hooft et al framework.

METHODS

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.

RESULTS

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.

LIMITATIONS: Usefulness scoring involves subjective judgment; non-English trials were excluded; the absence of formal risk of bias analysis limits interpretability of trial quality.

DISCUSSIONS/

CONCLUSIONS

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.