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

August 2, 2014 updated by: Leonardo Henrique Cunha Ferraro, Federal University of São Paulo

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 04024002
        • Federal University of Sao Paulo - Hospital Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: Ultrasound: Axillary block
Ultrasound guided axillary block
Drug: Ropivacaine
20 ml of ropivacaine 0,5% in both groups ( axillary block and infraclavicular block)
Active Comparator: 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.
Drug: Ropivacaine
20 ml of ropivacaine 0,5% in both groups ( axillary block and infraclavicular block)
Device: Ultrasound: Infraclavicular block
Ultrasound guided infraclvicular block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative analgesia
Time Frame: first postoperative day
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
local anesthetic pharmacokinetics
Time Frame: During the procedure
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.
During the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Study Director: Maria Angela Tardelli, PhD, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

March 1, 2015

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

July 30, 2014

First Submitted That Met QC Criteria

August 2, 2014

First Posted (Estimate)

August 5, 2014

Study Record Updates

Last Update Posted (Estimate)

August 5, 2014

Last Update Submitted That Met QC Criteria

August 2, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Infra Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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