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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary:

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 Summary:

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.

Current Primary Outcome: Time of block performance [ Time Frame: Measured directly during the procedure with a chronometer. Time of performance is composed of imaging time and needling time ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Imaging time [ Time Frame: Measured directly during the procedure with a chronometer. ]

  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

• Needling time [ Time Frame: Measured directly during the procedure with a chronometer. ]
  Corresponds to the time elapsed between the penetration of the skin with the needle until the complete removal of the needle from the tissues.
• Time to sensory loss evaluated at 10, 20 and 30 minutes after procedure [ Time Frame: Blind assistant evaluates the loss of sensibility in 5 precise nerve territories, 10, 20 and 30 minutes after the block. ]
  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
• Time to motor blockade evaluated at 10, 20 and 30 minutes after procedure [ Time Frame: Blind assistant evaluates the loss of motor function in four muscular groups at 10, 20 and 30 minutes after the block. ]
  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
• Success of plexus block [ Time Frame: Success is defined at end of surgery for which block was done, generally within 1 to 3 hours after block is performed ]
  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.
• Total anesthesia time [ Time Frame: Intraoperative ]
  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.
• Number of needle passes [ Time Frame: Number of needle passes required during procedure. ]
  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.
• Needle visualization [ Time Frame: Assessed one week after study completion ]
  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)
• Needle angle [ Time Frame: Assessed one week after study completion ]
  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.
• Same as current
  
  Information By: Université de Sherbrooke
  

  Dates:
  Date Received: September 12, 2016
  Date Started: September 2016
  Date Completion: September 2018
  Last Updated: November 14, 2016
  Last Verified: November 2016