NCT02208245

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 5, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

August 5, 2014

Status Verified

August 1, 2014

Enrollment Period

1.1 years

First QC Date

July 30, 2014

Last Update Submit

August 2, 2014

Conditions

Scaphoid FracturesDistal Radius FracturesWrist Injury Arthrodesis

Outcome Measures

Primary Outcomes (1)

  • postoperative analgesia

    All patients will be contacted on the first postoperative day to tell the time of onset of pain postoperatively. The duration of postoperative analgesia is defined as the interval between the end of local anesthetic injection and the onset of postoperative pain reported by the patient.

    first postoperative day

Secondary Outcomes (1)

  • local anesthetic pharmacokinetics

    During the procedure

Study Arms (2)

Ultrasound: Axillary block

ACTIVE COMPARATOR

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.

Device: Ultrasound: Axillary blockDrug: Ropivacaine

Ultrasound: Infraclavicular block

ACTIVE COMPARATOR

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.

Device: Ultrasound: Infraclavicular blockDrug: Ropivacaine

Interventions

Ultrasound: Axillary blockDEVICE

Ultrasound guided axillary block

Ultrasound: Axillary block
Ultrasound: Infraclavicular blockDEVICE

Ultrasound guided infraclvicular block

Ultrasound: Infraclavicular block
RopivacaineDRUG

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

Ultrasound: Axillary blockUltrasound: Infraclavicular block

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • cognitive impairment or active psychiatric condition
  • infection at the puncture site
  • bleeding disorders
  • history of allergy to ropivacaine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Sao Paulo - Hospital Sao Paulo

São Paulo, São Paulo, 04024002, Brazil

Location

Related Publications (9)

  • 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.

    PMID: 19574871BACKGROUND

  • 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.

    PMID: 21860745BACKGROUND

  • 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.

    PMID: 23684374BACKGROUND

  • 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.

    PMID: 19419356BACKGROUND

  • 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.

    PMID: 11097667BACKGROUND

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

    PMID: 12378663BACKGROUND

  • 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.

    PMID: 18713932BACKGROUND

  • 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.

    PMID: 16116009BACKGROUND

  • 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.

    PMID: 24565388BACKGROUND

MeSH Terms

Conditions

Wrist Fractures

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Maria Angela Tardelli, PhD

    Federal University of São Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 30, 2014

First Posted

August 5, 2014

Study Start

February 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

August 5, 2014

Record last verified: 2014-08

Locations

BR(1)