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

July 3, 2017 updated by: Pablo Echave, Université de Sherbrooke

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4G2
        • Centre Hospitalier de l'Université Laval [CHUL]
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universitaire de Sherbrooke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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
Measured directly during the procedure with a chronometer.
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.
Measured directly during the procedure with a chronometer.
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
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
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
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
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.
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
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.
Intraoperative
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.
Number of needle passes required during procedure.
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)
Assessed one week after study completion
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.
Assessed one week after study completion
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.
Assessed during the block
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.
Patients will be asked to report the level of discomfort they felt during the procedure
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.
Assessed during each block and again at 48 hours after the block

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Investigators

  • Principal Investigator: Pablo Echave, M.D., Université de Sherbrooke

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

September 12, 2016

First Submitted That Met QC Criteria

September 23, 2016

First Posted (Estimate)

September 26, 2016

Study Record Updates

Last Update Posted (Actual)

July 6, 2017

Last Update Submitted That Met QC Criteria

July 3, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-31-2017-1298

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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