Clinical trial NCT02913625: Retroclavicular Approach vs Infraclavicular Approach for Plexic Bloc Anesthesia of the Upper Limb
Official title: Retroclavicular Approach vs Infraclavicular Approach for Plexic Bloc Anesthesia of the Upper Limb: a Multi-centric Non-inferiority Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Injury
Keywords: Brachial plexus
Regional anesthesia
Infraclavicular
Retroclavicular
Parasagittal
Upper limb surgery
Ultrasound guided block
Coracoid
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2016-09-26
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time of block performance
timeFrame: Measured directly during the procedure with a chronometer. Time of performance is composed of imaging time and needling time
Secondary outcomes:
measure: Imaging time
timeFrame: Measured directly during the procedure with a chronometer.
measure: Needling time
timeFrame: Measured directly during the procedure with a chronometer.
measure: Time to sensory loss evaluated at 10, 20 and 30 minutes after procedure
timeFrame: Blind assistant evaluates the loss of sensibility in 5 precise nerve territories, 10, 20 and 30 minutes after the block.
measure: Time to motor blockade evaluated at 10, 20 and 30 minutes after procedure
timeFrame: Blind assistant evaluates the loss of motor function in four muscular groups at 10, 20 and 30 minutes after the block.
measure: Success of plexus block
timeFrame: Success is defined at end of surgery for which block was done, generally within 1 to 3 hours after block is performed
measure: Total anesthesia time
timeFrame: Intraoperative
measure: Number of needle passes
timeFrame: Number of needle passes required during procedure.
measure: Needle visualization
timeFrame: Assessed one week after study completion
measure: Needle angle
timeFrame: Assessed one week after study completion
measure: Neurostimulation use
timeFrame: Assessed during the block
measure: Pain during the procedure
timeFrame: Patients will be asked to report the level of discomfort they felt during the procedure
measure: Early and late complications:
timeFrame: Assessed during each block and again at 48 hours after the block
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
city: Quebec
country: Canada
facility: Centre Hospitalier de l'Université Laval [CHUL]
Study officials:
affiliation: Université de Sherbrooke
name: Pablo Echave, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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