Retroclavicular Approach vs Infraclavicular Approach for Plexic Bloc Anesthesia of the Upper Limb

Study Overview
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Brief Summary
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Locoregional anesthesia provides several advantages over general anesthesia in terms of postoperative pain, decreased postoperative opioid needs and reduced recovery time for patients undergoing orthopaedic surgery. For upper limb surgery, the coracoid infraclavicular brachial plexus block is generally preferred because of its simplicity and effectiveness but, needle visibility remains a challenge because of the angle between the ultrasound beam and the needle. The retroclavicular approach for brachial plexus anesthesia requires an angle between the needle and the ultrasound beam that is less steep than the angle required to perform an infraclavicular coracoid block. This approach has already been proven effective and safe in the past. The general objective is to provide a formal comparison between the retroclavicular approach and coracoid infraclavicular approach for brachial plexus anaesthesia. This study will delineate the differences between the two techniques.

Detailed Description
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Investigators aim is to compare both techniques in terms of scanning time, needling time, total anesthesia time, needle visibility, block needle passes, block success and early and late complications. Investigators made the hypothesis that, while providing similar efficacy and better needle visualisation than coracoid infraclavicular block, performance time of retroclavicular block will not exceed the performance time of its comparator. This study is designed as a prospective randomized non-inferiority trial. Two groups of non-consecutive patients will be randomly assigned to either retroclavicular or coracoid infraclavicular block. This study will be carried out in three different centres simultaneously. The multicentre trial will be conducted in two university hospitals (Centre hospitalier universitaire de Sherbrooke [CHUS] Hôtel-Dieu/Fleurimont and Centre Hospitalier de l'Université Laval [CHUL] in Quebec city) and a community hospital (Cowansville). The third participating establishment, Brome-Missisquoi-Perkins hospital, is located in Cowansville, a peripheral city of 15,000 people.

Official Title
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Retroclavicular Approach vs Infraclavicular Approach for Plexic Bloc Anesthesia of the Upper Limb: a Multi-centric Non-inferiority Randomised Controlled Trial

Conditions
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Hand Injury

Intervention / Treatment
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* Other: Ultrasound guided retroclavicular block
* Other: Ultrasound guided infraclavicular block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective or urgent surgery of the hand, wrist, forearm or elbow. Age >18 years old. ASA (American Society of Anesthesiologists) class 1, 2 and 3. Able to provide valid written consent. Minimum body weight of 50 kg, despite BMI Exclusion Criteria: Patient refusal. Previous surgery or gross anatomical deformity of the clavicle. Systemic or local infection at needle entry point. Coagulopathy. Severe pulmonary condition. Local anaesthetic allergy. Pre-existing neurologic symptoms in the ipsilateral limb. Pregnancy. Surgical request of an indwelling catheter for post-operative analgesia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound guided retroclavicular block<br>Patients assigned to this group will receive an ultrasound guided retroclavicular brachial plexus block | Other: Ultrasound guided retroclavicular block<br>* Ultrasound guided retroclavicular block for forearm or hand surgery<br>|
| Active Comparator: Ultrasound guided infraclavicular block<br>Patients assigned to this group will receive an ultrasound guided infraclavicular brachial plexus block | Other: Ultrasound guided infraclavicular block<br>* Ultrasound guided infraclavicular block for forearm or hand surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of block performance | The performance time corresponds to the sum of imaging time and needling time. It is expressed in minutes. Analysis of the primary outcome: performance time will be analyzed with a non-inferiority test of the averages, with the objective of finding that the experimental retroclavicular approach is no longer to perform than the coracoid infraclavicular approach. Subgroup analysis will be conducted to evaluate if higher body mass index influence (BMI) the outcomes, as the performance time, the needle visibility, the number of needle passes and the needle angle. Patient will be divided in two groups (higher and lower than the average BMI of all recruited patients) and analyzed according to their subgroup. If data is missing or if patient drop-out occurs, data will be analyzed with the intention-to-treat principle. | Measured directly during the procedure with a chronometer. Time of performance is composed of imaging time and needling time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Imaging time | Corresponds to the time interval between contact of the US probe with the patient skin and the acquisition of a satisfactory image. It is expressed in minutes. The secondary outcomes will all be analyzed with superiority analysis. For continuous data or ordinal data with >8 categories, data will be compiled as average and standard deviation. If data is parametric, student T test will be used and if not, Mann-Whitney test will be used. For dichotomic data (block success, use of neurostimulation), Chi square or Fisher exact test will be used depending if all n>5 or if not, respectively. Finally, for ordinal data Chi square will be used if data is parametric and Mann-Whitney will be used otherwise | Measured directly during the procedure with a chronometer. | 
| Needling time | Corresponds to the time elapsed between the penetration of the skin with the needle until the complete removal of the needle from the tissues. | Measured directly during the procedure with a chronometer. | 
| Time to sensory loss evaluated at 10, 20 and 30 minutes after procedure | Sensory loss will be assessed in the territory of the radial (lateral aspect of the dorsum of the hand), median (volar aspect of the index), ulnar (volar aspect of the fifth finger), musculocutaneous (lateral aspect of the forearm), and medial cutaneous nerve of the forearm (medial aspect of the forearm) distributions using a 3-point score, where 0 = normal sensation, 1 = diminished sensation to pinpricks (hypoesthesia), and 2 = loss of sensation to pinpricks (analgesia). The sum of five scores on a maximum of 10 will be the sensory loss final score. An independent, blinded, research assistant will complete the sensory assessment at 10, 20 and 30 minutes after procedure | Blind assistant evaluates the loss of sensibility in 5 precise nerve territories, 10, 20 and 30 minutes after the block. | 
| Time to motor blockade evaluated at 10, 20 and 30 minutes after procedure | Motor function will be tested (0 = normal strength, 1 = weakness, 2 = paralysis) for the radial (wrist extension), median (thumb-fifth finger opposition), ulnar (fifth finger abduction), and musculocutaneous (elbow flexion) nerves. The sum of the four scores on a maximum of 8 will be the motor block final score. An independent, blinded, research assistant will complete the motor assessment at 10, 20 and 30 minutes after procedure | Blind assistant evaluates the loss of motor function in four muscular groups at 10, 20 and 30 minutes after the block. | 
| Success of plexus block | Success is defined as the completion of surgery without the need for additional local anesthetics infiltration, intravenous narcotics, or general anesthesia. However, light sedation is allowed if deemed necessary by the anesthesiologist. Light sedation includes midazolam 1 to 4 mg intravenously, fentanyl up to 1 mcg/kg. A minimum sensory score of 9/10 will be necessary to proceed to surgery without additional local anesthetics infiltration. Patients with an overall sensory score less than 9/10 at 30 minutes will be offered general anesthesia or supplemental blocks. | Success is defined at end of surgery for which block was done, generally within 1 to 3 hours after block is performed | 
| Total anesthesia time | Measured in minutes and defined as the sum of performance time and time to achieve a minimum sensory score of 9/10. It is the time for readiness for surgery. | Intraoperative | 
| Number of needle passes | Defined as a unit of 1,2,3, etc. The number of times the block needle will have to be realigned at the skin in order to achieve its final positioning goal under the axillary artery. | Number of needle passes required during procedure. | 
| Needle visualization | Procedures will be videotaped and reviewed simultaneously after study completion by 2 independent anesthesiologists skilled in US-guided regional anesthesia using a 5-point Likert scale to rate needle visibility (1=very poor,2=poor,3=fair,4=good,5=very good). Needle visibility will be evaluated twice. First, for the retroclavicular approach, assessment will be done when needle tip is seen 1cm after crossing the clavicle acoustic shadowing. For the coracoid infraclavicular approach, the first assessment will be at a needle tip depth of 1 cm. Second needle visibility assessment will be immediately before local anesthetic injection when block needle is positioned under axillary artery (when the visibility is theoretically optimized) | Assessed one week after study completion | 
| Needle angle | Using the same videotape that investigators used for the evaluation of the needle visibility, the angle between the needle and the upper side of the ultrasound image will be noted. It will be a continuous outcome ranging from 0 to 90 degrees. | Assessed one week after study completion | 
| Neurostimulation use | Neurostimulation is accepted if needed. However, its use other than for safety sentinel (defined by <0,3 mA) will be recorded for subsequent analysis. It will be a dichotomic outcome. | Assessed during the block | 
| Pain during the procedure | Immediately after block completion, patients will be asked to rate their discomfort associated with the procedure using a 10-cm visual analogue scale (0 = no pain, 10 = worst pain imaginable) by an independent and blinded outcome assessor. | Patients will be asked to report the level of discomfort they felt during the procedure | 
| Early and late complications: | The incidence of needle-induced paresthesia, vascular puncture, Horner syndrome, dyspnea, and symptoms of local anesthetics toxicity will be noted. All patients will be contacted 48 hours after surgery to ask for any delayed complications, such as dyspnea, paresthesia, weaknesses, pain at the puncture site, hematoma. | Assessed during each block and again at 48 hours after the block | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Regional anesthesia, Brachial plexus, Infraclavicular, Retroclavicular, Parasagittal, Upper limb surgery, Ultrasound guided block, Coracoid