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Hand InjuryNCT02913625

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

A study testing Ultrasound guided retroclavicular block and Ultrasound guided infraclavicular block in people with Hand Injury, run by Université de Sherbrooke at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hand Injury
What is being tested?
Ultrasound guided retroclavicular block and Ultrasound guided infraclavicular block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
2 sitesCanada
Study dates
Sep 2016to Jun 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 9Show fewer
  • Pre-existing neurologic symptoms in the ipsilateral limb.
  • Pregnancy.
  • Surgical request of an indwelling catheter for post-operative analgesia

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Centre Hospitalier de l'Université Laval [CHUL]

    Québec, G1V 4G2

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

About this study

Official title: 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.

Read more

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.

Read the 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.

Conditions
Hand Injury
Being tested
Ultrasound guided retroclavicular block, Ultrasound guided infraclavicular block
Keywords
Brachial plexus, Regional anesthesia, Infraclavicular, Retroclavicular, Parasagittal, Upper limb surgery, Ultrasound guided block, Coracoid
Medical subject headings
Hand Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound guided retroclavicular blockOther

    Ultrasound guided retroclavicular block for forearm or hand surgery

  • Ultrasound guided infraclavicular blockOther

    Ultrasound guided infraclavicular block for forearm or hand surgery

Study groups in NCT02913625
Study groupRoleWhat they receive
Ultrasound guided retroclavicular blockExperimentalPatients assigned to this group will receive an ultrasound guided retroclavicular brachial plexus block
Receives: Other: Ultrasound guided retroclavicular block
Ultrasound guided infraclavicular blockActive comparatorPatients assigned to this group will receive an ultrasound guided infraclavicular brachial plexus block
Receives: Other: Ultrasound guided infraclavicular block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: Measured directly during the procedure with a chronometer. Time of performance is composed of imaging time and needling time

Secondary outcomes (12)

  1. 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: Measured directly during the procedure with a chronometer.

  2. 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: Measured directly during the procedure with a chronometer.

  3. 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

    Measured: Blind assistant evaluates the loss of sensibility in 5 precise nerve territories, 10, 20 and 30 minutes after the block.

  4. 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

    Measured: Blind assistant evaluates the loss of motor function in four muscular groups at 10, 20 and 30 minutes after the block.

  5. 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.

    Measured: Success is defined at end of surgery for which block was done, generally within 1 to 3 hours after block is performed

  6. 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.

    Measured: Intraoperative

  7. 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.

    Measured: Number of needle passes required during procedure.

  8. 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)

    Measured: Assessed one week after study completion

  9. 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.

    Measured: Assessed one week after study completion

  10. 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.

    Measured: Assessed during the block

  11. 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.

    Measured: Patients will be asked to report the level of discomfort they felt during the procedure

  12. 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.

    Measured: Assessed during each block and again at 48 hours after the block

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionMay 2017
  4. Study completionJun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02913625
Sponsor's protocol ID
MP-31-2017-1298
Status last verified
Jul 2017
First submitted
12 Sep 2016
Last updated
6 Jul 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Hadzic A, Arliss J, Kerimoglu B, Karaca PE, Yufa M, Claudio RE, Vloka JD, Rosenquist R, Santos AC, Thys DM. A comparison of infraclavicular nerve block versus general anesthesia for hand and wrist day-case surgeries. Anesthesiology. 2004 Jul;101(1):127-32. doi: 10.1097/00000542-200407000-00020.

    PubMed 15220781

  • Bruce BG, Green A, Blaine TA, Wesner LV. Brachial plexus blocks for upper extremity orthopaedic surgery. J Am Acad Orthop Surg. 2012 Jan;20(1):38-47. doi: 10.5435/JAAOS-20-01-038.

    PubMed 22207517

  • Chin KJ, Alakkad H, Adhikary SD, Singh M. Infraclavicular brachial plexus block for regional anaesthesia of the lower arm. Cochrane Database Syst Rev. 2013 Aug 28;2013(8):CD005487. doi: 10.1002/14651858.CD005487.pub3.

    PubMed 23986434

  • Lopez-Morales S, Moreno-Martin A, Leal del Ojo JD, Rodriguez-Huertas F. [Ultrasound-guided axillary block versus ultrasound-guided infraclavicular block for upper extremity surgery]. Rev Esp Anestesiol Reanim. 2013 Jun-Jul;60(6):313-9. doi: 10.1016/j.redar.2013.02.012. Epub 2013 May 15. Spanish.

    PubMed 23684374

  • Vermeylen K, Engelen S, Sermeus L, Soetens F, Van de Velde M. Supraclavicular brachial plexus blocks: review and current practice. Acta Anaesthesiol Belg. 2012;63(1):15-21.

    PubMed 22783706

  • Trehan V, Srivastava U, Kumar A, Saxena S, Singh CS, Darolia A. Comparison of two approaches of infraclavicular brachial plexus block for orthopaedic surgery below mid-humerus. Indian J Anaesth. 2010 May;54(3):210-4. doi: 10.4103/0019-5049.65362.

    PubMed 20885866

  • Minville V, Asehnoune K, Chassery C, N'Guyen L, Gris C, Fourcade O, Samii K, Benhamou D. Resident versus staff anesthesiologist performance: coracoid approach to infraclavicular brachial plexus blocks using a double-stimulation technique. Reg Anesth Pain Med. 2005 May-Jun;30(3):233-7. doi: 10.1016/j.rapm.2005.01.009.

    PubMed 15898025

  • de Gusmao LC, Lima JS, Ramalho Jda R, Leite AL, da Silva AM. Evaluation of brachial plexus fascicles involvement on infraclavicular block: unfixed cadaver study. Braz J Anesthesiol. 2015 May-Jun;65(3):213-6. doi: 10.1016/j.bjane.2014.06.010. Epub 2015 Feb 17.

    PubMed 25925034

  • Tsui, B.C.-H., Atlas of ultrasound and nerve stimulation-guided regional anesthesia. 2007: New York : Springer.

  • Hebbard P, Royse C. Ultrasound guided posterior approach to the infraclavicular brachial plexus. Anaesthesia. 2007 May;62(5):539. doi: 10.1111/j.1365-2044.2007.05066.x. No abstract available.

    PubMed 17448088

  • Charbonneau J, Frechette Y, Sansoucy Y, Echave P. The Ultrasound-Guided Retroclavicular Block: A Prospective Feasibility Study. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):605-9. doi: 10.1097/AAP.0000000000000284.

    PubMed 26222346

  • Beh ZY, Hasan MS, Lai HY, Kassim NM, Md Zin SR, Chin KF. Posterior parasagittal in-plane ultrasound-guided infraclavicular brachial plexus block-a case series. BMC Anesthesiol. 2015 Jul 21;15:105. doi: 10.1186/s12871-015-0090-0.

    PubMed 26194896

  • Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.

    PubMed 23303884

  • Tran DQ, Clemente A, Tran DQ, Finlayson RJ. A comparison between ultrasound-guided infraclavicular block using the "double bubble" sign and neurostimulation-guided axillary block. Anesth Analg. 2008 Sep;107(3):1075-8. doi: 10.1213/ane.0b013e31817ef259.

    PubMed 18713932

  • Yazer MS, Finlayson RJ, Tran DQ. A randomized comparison between infraclavicular block and targeted intracluster injection supraclavicular block. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):11-5. doi: 10.1097/AAP.0000000000000193.

    PubMed 25478758

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound guided retroclavicular block and Ultrasound guided infraclavicular block in people with Hand Injury, run by Université de Sherbrooke at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02913625, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2017.

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