The median effective analgesic dose (ED50) of ropivacaine in ultrasound-guided transversus abdominis plane block for analgesia in reversal of ileostomy: A double-blind up-down dose-finding study.

International audienceThe transversus abdominis plane block has become popular since it has been combined with ultrasound-guided techniques. In abdominal surgery, and especially in subumbilical surgery, it improves postoperative analgesia and reduces morphine consumption. Although it has been shown to be an effective technique, there are wide variations in reported doses and volumes of local anaesthetic used. The primary objective was to assess the median effective analgesic dose (ED50 = effective dose in 50% of patients) of ropivacaine in TAP blocks for patients undergoing reversal of ileostomy. A prospective double-blind study. French Teaching Hospital. Twenty-six colorectal patients were included. After standardised general anaesthesia, a unilateral ultrasound-guided TAP block was performed on patients undergoing elective reversal of ileostomy using 20 ml of ropivacaine. Doses were predefined according to the up-and-down method. The first patient received a dose of 1.6 mg kg. The dose adjustment interval was 0.2 ml kg. The potentially toxic dose of 3 mg kg was never exceeded. The primary endpoint was pain (defined as 3 or higher on a numerical pain scale of 0 to 10) at rest 6 h after TAP block. Out of the twenty-six patients who were included in the study, the ED50 of ropivacaine in TAP block for patients undergoing reversal of ileostomy was 2.70 mg kg [95% confidence interval (95% CI) 2.37 to 3.03 mg kg]. The ED50 of ropivacaine in TAP blocks in reversal of ileostomy is close to the toxic threshold. Anaesthesiologists should always be aware of the systemic toxicity risk and use weight-based doses when performing a TAP block

Study protocol for a multicentre, 2×2 factorial, randomised, controlled trial evaluating the interest of intravenous iron and tranexamic acid to reduce blood transfusion in hip fracture patients (the HiFIT study)

International audienceIntroduction Blood transfusion and anaemia are frequent and are associated with poor outcomes in patients with hip fracture (HF). We hypothesised that preoperative intravenous iron and tranexamic acid (TXA) may reduce the transfusion rate in these patients.Methods and analysis The HiFIT study is a multicentre, 2×2 factorial, randomised, double-blinded, controlled trial evaluating the effect of iron isomaltoside (IIM) (20 mg/kg) vs placebo and of TXA (intravenously at inclusion and topically during surgery) versus placebo on transfusion rate during hospitalisation, in patients undergoing emergency surgery for HF and having a preoperative haemoglobin between 95 and 130 g/L. 780 patients are expected. The primary endpoint is the proportion of patients receiving an allogenic blood transfusion of packed red blood cells from the day of surgery until hospital discharge (or until D30 if patient is still hospitalised). Enrolment started on March 2017 in 11 French hospitals. The study was stopped between July 2017 and August 2018 (because of investigation of serious AEs with IIM in Spain) and slowed down since March 2020 (COVID-19 crisis). The expected date of final follow-up is May 2022. Analyses of the intent-to-treat and per-protocol populations are planned.Ethics and dissemination The HiFIT trial protocol has been approved by the Ethics Committee of Comité de Protection des Personnes Ouest II and the French authorities (ANSM). It will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals. The HiFIT trial will be the largest study evaluating iron and TXA in patients with HF. Trial registration number clinicalTrials.gov identifier: NCT02972294 ; EudraCT Number 2016-003087-40