Retroclavicular approach vs infraclavicular approach for plexic bloc anesthesia of the upper limb: study protocol randomized controlled trial
Bibliographic record
Abstract
BACKGROUND: The coracoid approach is recognized as the simplest approach to perform brachial plexus anaesthesia, but needle visualization needs to be improved. With a different needle entry point, the retroclavicular approach confers a perpendicular angle between the ultrasound and the needle, which theoretically enhances needle visualization. This trial compares these two techniques. The leading hypothesis is that the retroclavicular approach is comparable to the infraclavicular coracoid approach in general aspects, but needle visualization is better with this novel approach. METHODS: We designed a multicentre, randomized, non-inferiority trial. Patients eligible for the study are older than 18 years, able to consent, will undergo urgent or elective upper limb surgery distal to the elbow and are classified with American Society of Anaesthesiologists risk score (ASA) I-III. They will be excluded if they meet contraindicated criteria to regional anaesthesia, have affected anatomy of the clavicle or are pregnant. Randomization will be done by a computer-generated randomization schedule stratified for each site and in 1:1 ratio, and concealment will be maintained with opaque, sealed envelopes in a locked office. The primary outcome, the performance time, will be analyzed using non-inferiority analysis while secondary outcomes will be analyzed with superiority analysis. Needle visualization will be ranked on a Likert scale of 1-5 that is subjective and represents a pitfall. Two separate persons will rank needle visualization to compensate this pitfall. According to previous studies, 49 patients per group are required for statistical power of 0.90 and one-sided type I error of 0.05. DISCUSSION: The conduct of this study will bring clear answers to our questions and, if our hypothesis is confirmed, will confer an anatomic alternative to difficult coracoid infraclavicular brachial blocks or could even become a standard for brachial plexus anaesthesia. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02913625 . Registered on 12 September 2016.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.028 | 0.007 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.006 | 0.003 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".