Retroclavicular approach vs infraclavicular approach for plexic bloc anesthesia of the upper limb: study protocol randomized controlled trial

Abstract

BackgroundThe 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.MethodsWe 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.DiscussionThe 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 registrationClinicalTrials.gov, NCT02913625. Registered on 12 September 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2086-1) contains supplementary material, which is available to authorized users.

Retroclavicular vs Infraclavicular block for brachial plexus anesthesia: a multi-centric randomized trial

“…All study participants provided written informed consent before randomization. A detailed study protocol was previously published [10, 13]. This study fully adhere to CONSORT guidelines [14].…”

Retroclavicular vs Infraclavicular block For Brachial Plexus Anesthesia: A Multi-Centric Randomized Trial

“…Immediately after complete LA bolus injection, an independent and blind outcome assessor evaluated procedural pain using a 10 cm visual analogue scale. Following our detailed protocol (13), number of needle passes (defined as positive integer unit each time the block needle needs to be realigned on the skin) as well as early and 48h complications (such as paresthesia, vascular puncture, Horner syndrome, dyspnea, etc.) were also documented.…”

“…We considered the use of neurostimulator as positive when the purpose of its use was not only for safety sentinel stimulation (<0.3 mA). Details of complications and follow-up assessments are presented in our protocol (13). Briefly, early complications were assessed on the day of surgery, all patients were further contacted 48h after surgery to query for any delayed complications (dyspnea, paresthesia, weaknesses, pain, at the puncture site or hematoma).…”

“…Sample size calculation for this study has been presented in detail previously (13). Briefly, it was calculated on the basis of a recent study (16) where the performance time for coracoid ICB approach was 5.6 min, with 45 s of visualization time and using our feasibility study recently conducted (10) where the needling time for the RCB approach was 3 min 42 sec.…”

“…Briefly, it was calculated on the basis of a recent study (16) where the performance time for coracoid ICB approach was 5.6 min, with 45 s of visualization time and using our feasibility study recently conducted (10) where the needling time for the RCB approach was 3 min 42 sec. As we explained in our published protocol (13) and based on our clinical judgement and statistical convention, we deemed that a time superiority of 5% would be significant and therefore have set the non-inferiority margin at 5%. An initial sample size of 49 patients per group was required to provide a statistical power of 0.9 (0.05 one-sided type 1 error), but to account for dropouts and inadequate procedures, the final sample size was set to 55 patients per group.…”