Effect of superficial and deep parasternal blocks on recovery after cardiac surgery: study protocol for a randomized controlled trial.

BACKGROUND: Pain is frequent after cardiac surgery and source of multiple complications that can impair postoperative recovery. Regional anesthesia seems to be an interesting technique to reduce the pain in this context, but its effectiveness in improving recovery has been poorly studied so far. The objective of this study is to compare the effectiveness of two of the most studied chest wall blocks in cardiac surgery, i.e., the superficial and the deep parasternal intercostal plane blocks (SPIP and DPIP respectively), in addition to standard care, versus the standard care without regional anesthesia, on the quality of postoperative recovery (QoR) after cardiac surgery with sternotomy. METHODS: This is a single-center, single-blind, controlled, randomized trial with a 1:1:1 ratio. Patients (n = 254) undergoing cardiac surgery with sternotomy will be randomized into three groups: a control group with standard care and no regional anesthesia, a SPIP group with standard care and a SPIP, and a DPIP with standard care and a DPIP. All groups will receive the usual analgesic protocol. The primary endpoint is the value of the QoR evaluated by the QoR-15 at 24 h after the surgery. DISCUSSION: This study will be the first powered trial to compare the SPIP and the DPIP on global postoperative recovery after cardiac surgery with sternotomy. TRIAL REGISTRATION: ClinicalTrials.gov NCT05345639. Registered on April 26, 2022.

Spin and fragility in randomised controlled trials in the anaesthesia literature: a systematic review.

BACKGROUND: Given variable frequency of misleading reports and the potential for spin (a way of describing results that can mislead readers) to influence interpretation of randomised controlled trials (RCTs), we have undertaken a spin reassessment. We evaluated the quality of recent literature in anaesthesia journals by assessing the presence of spin and calculating the fragility index. METHODS: This systematic review of randomised trials was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. We searched via PubMed® from January 1, 2019 to January 1, 2021 to identify all RCTs published in one of the 20 anaesthesia journals with the highest journal impact factors during this time. Four pairs of reviewers assessed articles independently for eligibility using a piloted electronic data extraction form. They assessed the presence of spin in statistically negative RCTs and calculated the fragility index for statistically positive RCTs. RESULTS: Of the 802 screened records, 162 (20%) articles were analysed for spin, and 65 (8%) trials were analysed for fragility index. For the statistically negative studies, 66 articles (40%) presented spin; 89% of these occurrences of spin were described in the conclusion of the abstract. The primary type of spin was the highlight of secondary outcomes (67%). For statistically positive trials, the median fragility index was 4 [1-8]. CONCLUSIONS: This systematic review showed that 40% of statistically negative trials in high-impact anaesthesia journals could mislead readers. For statistically positive RCTs, the results relied on few subjects, with a median fragility index of 4 [1-8]. Efforts must be continued to reduce spin and fragility in the medical literature.