A randomised controlled trial in patients undergoing arthroscopic shoulder surgery comparing interscalene block with either 10 ml or 20 ml levobupivacaine 0.25%

Abstract

Summary The interscalene brachial plexus block is recommended for analgesia after shoulder surgery but it may cause hemidiaphragmatic dysfunction. We tested whether ipsilateral hemidiaphragmatic contraction was better after a smaller dose of local anaesthetic without impairing analgesic effect. We randomly allocated 48 adults to 10 ml or 20 ml levobupivacaine 0.25% before arthroscopic shoulder surgery. The primary outcome was hemidiaphragmatic paralysis, defined as inspiratory thickness < 1.2 times expiratory thickness, measured by ultrasound 4 h after block. Hemidiaphragmatic paralysis was recorded for 6/24 vs. 23/24 supine participants after 10 ml vs. 20 ml levobupivacaine 0.25%, respectively, and for 4/24 vs. 23/24 sitting participants, respectively, p < 0.001 for both. Pain scores after 10 ml injectate were not worse than after 20 ml injectate. Median (IQR [range]) morphine doses in the first 24 postoperative hours after 10 ml and 20 ml levobupivacaine 0.25% were 2 (0–6 [0–23]) mg vs. 1 (0–2 [0–11]) mg, respectively, p = 0.12. No participant had a complication after 10 ml interscalene levobupivacaine, whereas seven had complications after 20 ml levobupivacaine, p = 0.009. Hemidiaphragmatic function was better after 10 ml vs. 20 ml interscalene levobupivacaine 0.25% without impairing analgesia for 24 postoperative hours.

Cost Analysis of Low-Volume Versus Standard-Volume Ultrasound-Guided Interscalene Brachial Plexus Block in Arthroscopic Shoulder Surgery

“…No delayed hospital discharge occurred in either group. All primary and secondary clinical outcomes were duly assessed [ 10 ]. During follow-up, no difference was observed between the groups in the influence of the COVID-19 pandemic (p = 0.296).…”

“…This is a post-hoc cost analysis of the REDOLEV trial, a phase III double-blind randomized prospective single-centre two-arm comparative controlled clinical trial [ 7 , 10 ]. The present report was drafted following the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) Statement [ 7 ].…”

“…Differences in operating room and length of stay in the PACU between the intervention and control groups were assessed through a t-test. The method followed to estimate the sample size (a power of 90% and a dropout rate of 10%) was specified in a previous article [ 10 ]. For all analyses, a statistically significant result was assumed if p<0.05.…”

“…In our earlier work, we demonstrated that reducing from 20 to 10 ml the volume of levobupivacaine 0.25% used for an ultrasound-guided interscalene block decreases the incidence of postoperative complications such as hemidiaphragmatic paralysis while providing non-inferior analgesia [ 10 ]. This post-hoc analysis was aimed at gaining a better understanding of the economic impact of anesthesia management in the context of arthroscopic shoulder surgery.…”

“…This post-hoc analysis was aimed at gaining a better understanding of the economic impact of anesthesia management in the context of arthroscopic shoulder surgery. The first step toward this goal was to estimate the difference in the use of healthcare resources and days on sick leave between the patients undergoing standard-volume and low-volume ultrasound-guided interscalene blocks included in the REDOLEV trial [ 10 ]. As a second step, an estimation was made of the difference between the total costs for both groups under the public healthcare payor and limited social perspectives.…”