Prospective Clinical Trial Comparing Infraclavicular Versus Axillary Approach to Brachial Plexus Block

NCT ID: NCT02208245

Last Updated: 2014-08-05

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-03-31

Brief Summary

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The brachial plexus block is an anesthetic technique often used for surgical procedures of the upper limb. To get the brachial plexus block, several routes can be used, including the axillary and infraclavicular approach.

Few studies have compared these techniques, considering the time to perform the block, the onset time and success rate, with conflicting results. Furthermore, there is little information in the literature comparing the length of postoperative analgesia provided by these techniques.

Therefore, the investigators designed this study in order to elucidate the differences between these two techniques to assist the anesthesiologist to choose the best of them in clinical practice.

Detailed Description

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Conditions

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Scaphoid Fractures Distal Radius Fractures Wrist Injury Arthrodesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Ultrasound: Axillary block

For the axillary group, the ultrasound probe will be placed upright in the armpit to obtain a cross section of this region. After visualization of the nerves form the brachial plexus by ultrasound, 5 mL of ropivacaine 0.5% will be injected around each nerve to be blocked (median, ulnar, radial and musculocutaneous). If resistance to the injection of the solution is present or the patient complains of severe pain, the needle will be immediately repositioned.

Group Type ACTIVE_COMPARATOR

Ultrasound: Axillary block

Intervention Type DEVICE

Ultrasound guided axillary block

Ropivacaine

Intervention Type DRUG

20 ml of ropivacaine 0,5% in both groups ( axillary block and infraclavicular block)

Ultrasound: Infraclavicular block

For the infraclavicular group, the ultrasound probe will be placed in the infraclavicular region (the junction between the clavicle and the coracoid process) to obtain a cross-sectional imaging of the axillary artery. After visualization of the axillary artery by ultrasound, the block will be performed using the technique in plan for visualization of the needle. The needle is placed in position 6-8 hours of the artery, and 20 mL of ropivacaine 0.5% will be injected, observing a dispersal of local anesthetic around the artery.

Group Type ACTIVE_COMPARATOR

Ultrasound: Infraclavicular block

Intervention Type DEVICE

Ultrasound guided infraclvicular block

Ropivacaine

Intervention Type DRUG

20 ml of ropivacaine 0,5% in both groups ( axillary block and infraclavicular block)

Interventions

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Ultrasound: Axillary block

Ultrasound guided axillary block

Intervention Type DEVICE

Ultrasound: Infraclavicular block

Ultrasound guided infraclvicular block

Intervention Type DEVICE

Ropivacaine

20 ml of ropivacaine 0,5% in both groups ( axillary block and infraclavicular block)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age older than 18 years and less than 70 years
* consent informed signed by the patient
* candidates for surgical intervention of scaphoid fractures, distal radius fractures and wrist arthrodesis
* American Society of Anesthesiology physical status I, II and III
* body mass index (BMI) \<35 kg / m².

Exclusion Criteria

* cognitive impairment or active psychiatric condition
* infection at the puncture site
* bleeding disorders
* history of allergy to ropivacaine
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Leonardo Henrique Cunha Ferraro

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Angela Tardelli, PhD

Role: STUDY_DIRECTOR

Federal University of São Paulo

Locations

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Federal University of Sao Paulo - Hospital Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Tran DQ, Russo G, Munoz L, Zaouter C, Finlayson RJ. A prospective, randomized comparison between ultrasound-guided supraclavicular, infraclavicular, and axillary brachial plexus blocks. Reg Anesth Pain Med. 2009 Jul-Aug;34(4):366-71. doi: 10.1097/AAP.0b013e3181ac7d18.

Reference Type BACKGROUND
PMID: 19574871 (View on PubMed)

Song IA, Gil NS, Choi EY, Sim SE, Min SW, Ro YJ, Kim CS. Axillary approach versus the infraclavicular approach in ultrasound-guided brachial plexus block: comparison of anesthetic time. Korean J Anesthesiol. 2011 Jul;61(1):12-8. doi: 10.4097/kjae.2011.61.1.12. Epub 2011 Jul 21.

Reference Type BACKGROUND
PMID: 21860745 (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)

Koscielniak-Nielsen ZJ, Frederiksen BS, Rasmussen H, Hesselbjerg L. A comparison of ultrasound-guided supraclavicular and infraclavicular blocks for upper extremity surgery. Acta Anaesthesiol Scand. 2009 May;53(5):620-6. doi: 10.1111/j.1399-6576.2009.01909.x.

Reference Type BACKGROUND
PMID: 19419356 (View on PubMed)

Ootaki C, Hayashi H, Amano M. Ultrasound-guided infraclavicular brachial plexus block: an alternative technique to anatomical landmark-guided approaches. Reg Anesth Pain Med. 2000 Nov-Dec;25(6):600-4. doi: 10.1053/rapm.2000.18184.

Reference Type BACKGROUND
PMID: 11097667 (View on PubMed)

Sandhu NS, Capan LM. Ultrasound-guided infraclavicular brachial plexus block. Br J Anaesth. 2002 Aug;89(2):254-9. doi: 10.1093/bja/aef186.

Reference Type BACKGROUND
PMID: 12378663 (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)

Arcand G, Williams SR, Chouinard P, Boudreault D, Harris P, Ruel M, Girard F. Ultrasound-guided infraclavicular versus supraclavicular block. Anesth Analg. 2005 Sep;101(3):886-890. doi: 10.1213/01.ANE.0000159168.69934.CC.

Reference Type BACKGROUND
PMID: 16116009 (View on PubMed)

Ferraro LH, Takeda A, dos Reis Falcao LF, Rezende AH, Sadatsune EJ, Tardelli MA. Determination of the minimum effective volume of 0.5% bupivacaine for ultrasound-guided axillary brachial plexus block. Braz J Anesthesiol. 2014 Jan-Feb;64(1):49-53. doi: 10.1016/j.bjane.2013.03.014. Epub 2013 Dec 2.

Reference Type BACKGROUND
PMID: 24565388 (View on PubMed)

Other Identifiers

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Infra Study

Identifier Type: -

Identifier Source: org_study_id

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