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

Primary Purpose

Scaphoid Fractures, Distal Radius Fractures, Wrist Injury Arthrodesis

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Ultrasound: Axillary block
Ultrasound: Infraclavicular block
Ropivacaine
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scaphoid Fractures

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of Sao Paulo - Hospital Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ultrasound: Axillary block

Ultrasound: Infraclavicular block

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

local anesthetic pharmacokinetics
Venous blood samples will be taken from some patients through a cannula. The samples will be used for the determination of serum levels achieved after ropivacaine blockade. Samples will be taken every 15 minutes during the first hour, every 30 minutes during the second hour and 4 hours after the blockade. These samples will be analyzed using the technique of high performance liquid chromatography coupled with mass spectrometry.

Full Information

First Posted
July 30, 2014
Last Updated
August 2, 2014
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02208245
Brief Title
Prospective Clinical Trial Comparing Infraclavicular Versus Axillary Approach to Brachial Plexus Block
Official Title
Prospective Randomized Clinical Trial Comparing Infraclavicular Versus Axillary Approach to Brachial Plexus Block.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scaphoid Fractures, Distal Radius Fractures, Wrist Injury Arthrodesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound: Axillary block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Ultrasound: Infraclavicular block
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Ultrasound: Axillary block
Intervention Description
Ultrasound guided axillary block
Intervention Type
Device
Intervention Name(s)
Ultrasound: Infraclavicular block
Intervention Description
Ultrasound guided infraclvicular block
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
20 ml of ropivacaine 0,5% in both groups ( axillary block and infraclavicular block)
Primary Outcome Measure Information:
Title
postoperative analgesia
Description
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.
Time Frame
first postoperative day
Secondary Outcome Measure Information:
Title
local anesthetic pharmacokinetics
Description
Venous blood samples will be taken from some patients through a cannula. The samples will be used for the determination of serum levels achieved after ropivacaine blockade. Samples will be taken every 15 minutes during the first hour, every 30 minutes during the second hour and 4 hours after the blockade. These samples will be analyzed using the technique of high performance liquid chromatography coupled with mass spectrometry.
Time Frame
During the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Angela Tardelli, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Federal University of Sao Paulo - Hospital Sao Paulo
City
Sao Paulo
ZIP/Postal Code
04024002
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
19574871
Citation
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.
Results Reference
background
PubMed Identifier
21860745
Citation
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.
Results Reference
background
PubMed Identifier
23684374
Citation
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.
Results Reference
background
PubMed Identifier
19419356
Citation
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.
Results Reference
background
PubMed Identifier
11097667
Citation
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.
Results Reference
background
PubMed Identifier
12378663
Citation
Sandhu NS, Capan LM. Ultrasound-guided infraclavicular brachial plexus block. Br J Anaesth. 2002 Aug;89(2):254-9. doi: 10.1093/bja/aef186.
Results Reference
background
PubMed Identifier
18713932
Citation
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.
Results Reference
background
PubMed Identifier
16116009
Citation
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.
Results Reference
background
PubMed Identifier
24565388
Citation
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.
Results Reference
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Prospective Clinical Trial Comparing Infraclavicular Versus Axillary Approach to Brachial Plexus Block

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