Retroclavicular Approach vs Infraclavicular Approach for Plexic Bloc Anesthesia of the Upper Limb
|ClinicalTrials.gov Identifier: NCT02913625|
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : July 6, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Hand Injury||Other: Ultrasound guided retroclavicular block Other: Ultrasound guided infraclavicular block||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Retroclavicular Approach vs Infraclavicular Approach for Plexic Bloc Anesthesia of the Upper Limb: a Multi-centric Non-inferiority Randomised Controlled Trial|
|Study Start Date :||September 2016|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||June 2017|
Experimental: Ultrasound guided retroclavicular block
Patients assigned to this group will receive an ultrasound guided retroclavicular brachial plexus block
Other: Ultrasound guided retroclavicular block
Ultrasound guided retroclavicular block for forearm or hand surgery
Active Comparator: Ultrasound guided infraclavicular block
Patients assigned to this group will receive an ultrasound guided infraclavicular brachial plexus block
Other: Ultrasound guided infraclavicular block
Ultrasound guided infraclavicular block for forearm or hand surgery
- 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 ]
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.
- 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.
- Neurostimulation use [ Time Frame: Assessed during the block ]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.
- Pain during the procedure [ Time Frame: Patients will be asked to report the level of discomfort they felt 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.
- Early and late complications: [ Time Frame: Assessed during each block and again at 48 hours after the block ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913625
|Centre Hospitalier Universitaire de Sherbrooke|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Centre Hospitalier de l'Université Laval [CHUL]|
|Quebec, Canada, G1V 4G2|
|Principal Investigator:||Pablo Echave, M.D.||Université de Sherbrooke|