Protocol Study for the Evaluation of Non-Opioid Balanced General Anaesthesia in Cardiac Surgery with Cardiopulmonary Bypass: A Randomised, Controlled, Multicentric Superiority Trial (OFACAR Study).

Opioid-free anaesthesia (OFA) is general anaesthesia based on the use of several non-opioid molecules that aim to have an analgesic effect, decrease the sympathetic response, decrease hormonal stress, and decrease the inflammatory response during surgery. Although this approach to anaesthesia is regularly used in clinical practice, it remains a novel approach. The literature on this anaesthesia modality finds a number of positive effects on cardiac, respiratory, and cognitive function but no randomised study evaluated these effects during cardiac surgery where there is a high incidence of postoperative complications. The main aim of the study is to compare OFA vs. standard balanced opioid general anaesthesia on the incidence of postoperative complications and the length of stay in intensive care and hospital. OFACAR is a multicentric, randomised, controlled, superiority, single-blind, two parallel-arm clinical trial in patients undergoing cardiac surgery with cardiopulmonary bypass. We compared a balanced general anaesthesia without opioids (OFA group) vs. a balanced opioid general anaesthesia with sufentanil (control group). One hundred and sixty patients will be enrolled in each treatment group. The primary endpoint is a composite one which corresponds to the occurrence of at least one of the postoperative complications, defined according to European standards within 30 days after surgery. Recruitment started in September 2019, and data collection is expected to end in November 2024.

Clinical effectiveness of single dose of intravenous dexamethasone on the duration of ropivacaine axillary brachial plexus block: the randomized placebo-controlled ADEXA trial.

BACKGROUND AND OBJECTIVES: The effect of intravenous dexamethasone on the duration of axillary plexus block performed using ropivacaine is not described. The aim of this study is to assess the effect of intravenous dexamethasone on the duration of axillary plexus block analgesia after distal upper arm surgery. METHODS: In this prospective, randomized, placebo-controlled, double-blinded trial, consenting patients scheduled for hand or forearm surgery under ultrasound-guided axillary plexus block performed using 0.5 mL/kg of 0.475% ropivacaine, were randomized to receive an intravenous injection of either 8 mg/2 mL of dexamethasone (Dexa group) or 2 mL of saline (Control). The primary outcome was the time of first analgesic intake after axillary block. Secondary outcomes included motor or sensory block duration, total use of postoperative analgesics, and block-related complications. RESULTS: Among the 98 patients included, 6 and 2 patients did not require postoperative analgesic intake in Dexa and Control groups, respectively (p=0.06). The time of first analgesic intake was significantly longer in the Dexa (20.9±9.3 hours) than in the Control group (14.7±6.6 hours, p<0.0004). Motor and sensory recovery occurred significantly later, and total analgesic consumption was lower in the Dexa than in the Control group. No nerve complication related to intravenous dexamethasone injection was recorded. CONCLUSIONS: This study showed that intravenous dexamethasone delayed for 6 hours the time to first analgesic intake after upper arm surgery under axillary plexus block performed with the long-lasting local anesthetic ropivacaine. This suggests that intravenous dexamethasone could be an interesting adjuvant to axillary plexus block. TRIAL REGISTRATION NUMBER: NCT02862327.