ArticleTrials2021
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.
Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04797312 (Comparison of an Opioid-Free Anesthesia Protocol Versus Standard Practices on Early and Late Post-operative Recovery), which is not on this map. Cited by 6 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Comparison of an Opioid-Free Anesthesia Protocol Versus Standard Practices on Early and Late Post-operative Recovery
Who cites it
6 citing papers in PubMed, 15 citations in OpenAlex.
- The effect of preemptive intravenous paracetamol-mannitol on postoperative analgesia and quality of recovery in elderly patients undergoing total hip arthroplasty.BMC anesthesiology · 2026Trial
- Opioid-free anesthesia with ultrasound-guided quadratus lumborum block in the supine position for lower abdominal or pelvic surgery: a randomized controlled trial.Scientific reports · 2024Trial
- The Effect of Opioid-Free Anesthesia with Transversus Abdominis Plane Block on Patients Undergoing Laparoscopic Sleeve Gastrectomy: Randomized Controlled Study.Journal of pain research · 2024Trial
- Opioid-Free Anesthesia for Mandibular Surgery in a Patient With Confirmed Opioid Hypersensitivity: A Case Report.Cureus · 2026Article
- The Postoperative Lidocaine and Ketamine Effects on Morphine Requirement in Bariatric Surgery.Obesity surgery · 2025Article
- Opioid-free anesthesia reduces the severity of acute postoperative motion-induced pain and patient-controlled epidural analgesia-related adverse events in lung surgery: randomized clinical trial.Frontiers in medicine · 2023Article
Corrections and comments
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Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSince 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.
methodsThe 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 registrationClinicalTrials.gov NCT04797312. Registered on 15 March 2021.
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