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

NCT ID: NCT02913625

Last Updated: 2017-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-06-30

Brief Summary

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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

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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

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Hand Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Ultrasound guided retroclavicular block

Patients assigned to this group will receive an ultrasound guided retroclavicular brachial plexus block

Group Type EXPERIMENTAL

Ultrasound guided retroclavicular block

Intervention Type OTHER

Ultrasound guided retroclavicular block for forearm or hand surgery

Ultrasound guided infraclavicular block

Patients assigned to this group will receive an ultrasound guided infraclavicular brachial plexus block

Group Type ACTIVE_COMPARATOR

Ultrasound guided infraclavicular block

Intervention Type OTHER

Ultrasound guided infraclavicular block for forearm or hand surgery

Interventions

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Ultrasound guided retroclavicular block

Ultrasound guided retroclavicular block for forearm or hand surgery

Intervention Type OTHER

Ultrasound guided infraclavicular block

Ultrasound guided infraclavicular block for forearm or hand surgery

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Pablo Echave

Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pablo Echave, M.D.

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

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Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status

Centre Hospitalier de l'Université Laval [CHUL]

Québec, , Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 15220781 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22207517 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23986434 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23684374 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22783706 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20885866 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15898025 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25925034 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 17448088 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26222346 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26194896 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23303884 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18713932 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25478758 (View on PubMed)

Blanco AFG, Laferriere-Langlois P, Jessop D, D'Aragon F, Sansoucy Y, Albert N, Tetreault P, Echave P. Retroclavicular vs Infraclavicular block for brachial plexus anesthesia: a multi-centric randomized trial. BMC Anesthesiol. 2019 Oct 27;19(1):193. doi: 10.1186/s12871-019-0868-6.

Reference Type DERIVED
PMID: 31656165 (View on PubMed)

Langlois PL, Gil-Blanco AF, Jessop D, Sansoucy Y, D'Aragon F, Albert N, Echave P. Retroclavicular approach vs infraclavicular approach for plexic bloc anesthesia of the upper limb: study protocol randomized controlled trial. Trials. 2017 Jul 21;18(1):346. doi: 10.1186/s13063-017-2086-1.

Reference Type DERIVED
PMID: 28732521 (View on PubMed)

Other Identifiers

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MP-31-2017-1298

Identifier Type: -

Identifier Source: org_study_id

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