Analgesic efficacy of erector spinae plane block versus paravertebral block in lung surgeries—A non‐inferiority randomised controlled trial

Abstract

BackgroundPain management plays an essential role in postoperative recovery after lung surgeries. The Erector Spinae Plane Block (ESPB) is a widely used regional anaesthesia technique; however, few clinical trials have compared this block to active control in thoracic surgeries. This study evaluated the non‐inferiority of the analgesia provided by ESPB when compared to paravertebral block (PVB) in lung surgeries.MethodsRandomised, active‐controlled, blinded for patients and assessors, non‐inferiority trial. Patients who underwent unilateral lung surgeries were divided into two groups according to the regional anaesthesia technique—continuous ESPB or PVB at the T5 level. The primary outcome was to assess pain using a numerical rating scale (NRS) with a test of the interaction of three measures over 24 h postoperatively. An NRS score ≥ 7 was considered analgesia failure, and the prespecified non‐inferiority margin was 10%.ResultsIn the interim analysis that terminated this study, 120 participants were enrolled. ESPB patients reported higher mean NRS general values over 24 h, 4.6 ± 3.2 in the ESPB group versus 3.9 ± 2.9 in the PVB group, with a difference of −0.67 (−15.2%) and 95%CI: −1.29 to −0.05 (p = .02), demonstrating not non‐inferiority. In addition, the ESPB group presented higher NRS failure of analgesia over 24 h (p < .01) and required more postoperative opioids (p = .01 over 24 h). There was no difference in patient satisfaction between groups.ConclusionThis trial demonstrated that a continuous erector spinae plane block was not non‐inferior to a continuous paravertebral block for analgesia after lung surgery but resulted in higher levels of postoperative pain and opioid consumption.

Research design is important in comparing the analgesic efficacy of different regional blocks following modified radical mastectomy

“…[ 4 ] Thus, a non-inferiority margin of 1.0 points is often selected in randomised controlled non-inferiority trials comparing the postoperative analgesic efficacy of different regional blocks. [ 5 6 ]…”

“…In designing a randomised controlled non-inferiority trial, the non-inferiority margin is actually the effect size and is used for sample size evaluation[ 3 ] as performed in other works. [ 5 6 ]…”