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Abstract
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Background and Aims Large, randomized trials in regional anesthesia are challenging for many reasons including cumbersome recruitment, high cost, and complicated logistics. Pragmatic trials integrated into routine clinical practice offer an alternative to traditional randomized controlled trials. They employ simplified logistics while retaining key elements like randomization thus enabling rapid enrollment of large numbers of patients at low cost. We present our experience successfully implementing a large, pragmatic trial in busy clinical practice with no additional research funding.
Methods After IRB approval, patients were randomized to receive one of three ‘standard of care’ regional block approaches for mastectomy on a monthly basis. Day-of-surgery study consent was obtained by the anesthesiologist and all trial-eligible patients received the randomized block regardless of study participation. Recruitment and participant details are presented.
Results Between 8/21/2019 and 4/4/2023, 1756 subjects were screened for eligibility; 1508 (86%) consented to trial participation; and 1506 subjects were included in the analysis (figure 1). One patient (0.07%) experienced a block-related adverse event. 492 patients received paravertebral (PVB) blocks, 446 patients received combined PVB and interpectoral (PECS-1) blocks, and 567 patients received combined PECS-1 and serratus plane blocks. The three groups were extremely similar (table 1).
Patient characteristics by randomization arm. Data are presented as n (%) and median (IQR)
Participant flow diagram
Conclusions Our results suggest that although selection bias is possible with monthly randomization and individual patient consent, it was not observed in this trial, perhaps expected given the very high percentage of eligible patients accrued (86%). Clinically integrated trials serve as a template for other investigations in regional anesthesia to investigate the optimal regional anesthetic technique for a particular procedure.