Opioid-free Anesthesia Protocol on the Early Quality of Recovery after Major Surgery (SOFA Trial): A Randomized Clinical Trial.

BACKGROUND: Opioid-free anesthesia is increasingly being adopted to reduce opioid consumption, but its impact on early postoperative recovery after major surgery has not been evaluated in comparative trials. The hypothesis was that an opioid-free anesthesia protocol would enhance the early quality of recovery for patients undergoing scheduled major surgery under general anesthesia. METHODS: The SOFA study was a monocentric, randomized, controlled, assessor- and patient-blinded clinical trial conducted from July 10, 2021, to February 12, 2022. The eligible population included male and female patients undergoing scheduled major surgery, excluding bone procedures, that typically require opioids for postoperative pain management. Patients in the intervention group received a combination of at least two drugs among ketamine, lidocaine, clonidine, and magnesium sulfate, without opioids for anesthesia. The standard group received opioids. The primary outcome was early postoperative quality of recovery, assessed by Quality of Recovery-15 score at 24 h after surgery. Secondary outcomes were Quality of Recovery-15 at 48 and 72 h after surgery, incidence of chronic pain, and quality of life at 3 months. RESULTS: Of the 136 randomized patients, 135 were included in the primary analysis (mean age, 45.9 ± 15.7 yr; 116 females [87.2%]; 85 underwent major plastic surgery [63.9%]), with 67 patients in the opioid-free anesthesia group and 68 in the standard group. The mean Quality of Recovery-15 at 24 h was 114.9 ± 15.2 in the opioid-free anesthesia group versus 108.7 ± 18.1 in the standard group (difference, 6.2; 95% CI, 0.4 to 12.0; P = 0.026). Quality of Recovery-15 scores also differed significantly at 48 h (difference, 8.7; 95% CI, 2.9 to 14.5; P = 0.004) and at 72 h (difference, 7.3; 95% CI, 1.6 to 13.0; P = 0.013). There were no differences in other secondary outcomes. No major adverse events were noticed. CONCLUSIONS: The opioid-free anesthesia protocol improved quality of recovery after major elective surgery in a statistically but not clinically significant manner when compared to standard anesthesia.

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.

The effect of opioid-free anesthesia protocol on the early quality of recovery after major surgery (SOFA trial): study protocol for a prospective, monocentric, randomized, single-blinded trial.

BACKGROUND: Since the 2000s, opioid-free anesthesia (OFA) protocols have been spreading worldwide in anesthesia daily practice. These protocols avoid using opioid drugs during anesthesia to prevent short- and long-term opioid side effects while ensuring adequate analgesic control and optimizing postoperative recovery. Proofs of the effect of OFA protocol on optimizing postoperative recovery are still scarce. The study aims to compare the effects of an OFA protocol versus standard anesthesia protocol on the early quality of postoperative recovery (QoR) from major surgeries. METHODS: The SOFA trial is a prospective, randomized, parallel, single-blind, monocentric study. Patients (n = 140) scheduled for major plastic, visceral, urologic, gynecologic, or ear, nose, and throat (ENT) surgeries will be allocated to one of the two groups. The study group (OFA group) will receive a combination of clonidine, magnesium sulfate, ketamine, and lidocaine. The control group will receive a standard anesthesia protocol based on opioid use. Both groups will receive others standard practices for general anesthesia and perioperative care. The primary outcome measure is the QoR-15 value assessed at 24 h after surgery. Postoperative data such as pain intensity, the incidence of postoperative complication, and opioid consumption will be recorded. We will also collect adverse events that may be related to the anesthetic protocol. Three months after surgery, the incidence of chronic pain and the quality of life will be evaluated by phone interview. DISCUSSION: This will be the first study powered to evaluate the effect of OFA versus a standard anesthesia protocol using opioids on global postoperative recovery after a wide range of major surgeries. The SOFA trial will also provide findings concerning the OFA impact on chronic pain incidence and long-term patient quality of life. TRIAL REGISTRATION: ClinicalTrials.gov NCT04797312. Registered on 15 March 2021.