NCT01838928

Brief Summary

Background: The use of ultrasound in regional anesthesia enables a reduction in the local anesthetic volume. The present study aimed to determine the minimum effective concentration (EC50 and EC95) of bupivacaine for axillary brachial plexus block (ABPB). Methods: Following approval by the Research Ethics Committee, patients with a physical condition of I or II according to the American Society of Anesthesiologists, between 21 and 65 years of age were recruited and subjected to elective surgery of the hand and ABPB. The concentration of the anesthetic was determined using a step-up/step-down method and was based on the outcome of the preceding block.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Aug 2010

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2013

Completed
Last Updated

April 24, 2013

Status Verified

April 1, 2013

Enrollment Period

4 months

First QC Date

April 22, 2013

Last Update Submit

April 23, 2013

Conditions

Keywords

Axillary brachial plexus blockUltrasoundMinimum effective concentrationBupivacaineultrasound-guided axillary brachial plexus block

Outcome Measures

Primary Outcomes (1)

  • Minimum effective concentration of bupivacaine in ultrasound-guided axillary brachial plexus block

    2 years

Study Arms (1)

Bupivacaine

EXPERIMENTAL
Drug: Bupivacaine

Interventions

Bupivacaine

Eligibility Criteria

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

You may qualify if:

  • patients with a physical condition of I or II according to the American Society of Anesthesiologists,
  • between 18 and 65 years of age
  • unilateral hand surgery
  • BMI\< 35 kg;m@

You may not qualify if:

  • contraindication to regional anesthesia
  • bleeding diathesis
  • inability to visualize one or more nerves in the axilla
  • psychiatric history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04024-002, Brazil

Location

Related Publications (1)

  • Takeda A, Ferraro LH, Rezende AH, Sadatsune EJ, Falcao LF, Tardelli MA. Minimum effective concentration of bupivacaine for axillary brachial plexus block guided by ultrasound. Braz J Anesthesiol. 2015 May-Jun;65(3):163-9. doi: 10.1016/j.bjane.2013.11.007. Epub 2015 Feb 16.

MeSH Terms

Conditions

Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Leonardo HC Ferraro, M.D.

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

April 22, 2013

First Posted

April 24, 2013

Study Start

August 1, 2010

Primary Completion

December 1, 2010

Study Completion

June 1, 2012

Last Updated

April 24, 2013

Record last verified: 2013-04

Locations