Ropivacaine Volume for Ultrasound-guided Retrograde Infraclavicular Brachial Plexus Block

April 12, 2011 updated by: Beijing Jishuitan Hospital
The retrograde infraclavicular brachial plexus block has been proved an effective and safe approach. Realtime ultrasound guide will facilitate a successful peripheral nerve block. The purpose of this study was to determine the medium effective volume required to produce an effective retrograde infraclavicular block using an ultrasound (US)-guided technique.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thirty adults undergoing elective upper limb surgery received an US-guided retrograde infraclavicular block. The initial concentration of 0.5% ropivacaine injected was 30 ml, which was subsequently varied at a ratio of 1: 1.2 for each consecutive patient according to the response of the previous patient. The medium effective volume (EV50) was determined using the Dixon and Massey up-and-down method. The effective volume in 95% of patients (EV95) was calculated using probit regression.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

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

  • China
      • Beijing, China, 100035
        • Beijing Jishuitan Hospital

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:

  • Elected upper extremity operations
  • BMI 17~30kg/m2
  • ASA I/II

Exclusion Criteria:

  • Infection at injection site
  • Sepsis
  • Coagulation Dysfunction
  • Phrenic nerve palsy
  • Pneumothorax
  • Recurrent laryngeal nerve palsy
  • Clavicle fracture combined with nerve damage

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

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ropivacaine volume titration
Procedure: appropriate volume of 0.5% ropivacaine
initial concentration: 30 ml, subsequently varied at a ratio of 1: 1.2 for each consecutive patient according to the response of the previous patient, until 5 up-and-down cycles completed.
Other Names:
  • Naropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS of brachial plexus innervated area
Time Frame: 20 minutes
effect and side effects of the present block approach for brachial plexus.
20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
medium effective ropivacaine volume
Time Frame: about 2 months
The initial concentration of 0.5% ropivacaine injected was 30 ml, which was subsequently varied at a ratio of 1: 1.2 for each consecutive patient according to the response of the previous patient. The medium effective volume (EV50) was determined using the Dixon and Massey up-and-down method. EV95 was calculated using probit regression.
about 2 months

Collaborators and Investigators

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

Sponsor

Beijing Jishuitan Hospital

Investigators

  • Principal Investigator: Xiaoguang Zhang, MB, Department of Anesthesiology, Beijing Jishuitan Hospital, Beijing, China

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

March 1, 2010

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

April 7, 2011

First Submitted That Met QC Criteria

April 12, 2011

First Posted (Estimate)

April 13, 2011

Study Record Updates

Last Update Posted (Estimate)

April 13, 2011

Last Update Submitted That Met QC Criteria

April 12, 2011

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JSTMZ.2

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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