The Minimum Effective Concentration of Ropivacaine in Ultrasound-guided Supraclavicular Block

July 25, 2015 updated by: Fang Gang, Huazhong University of Science and Technology
The aim of this study is to determine the minimum effective concentration of local anesthetic (ropivacaine 40mL) required to produce an effective double-injection USG-SCB for surgical anesthesia in 90% of patients (MEC90) in young group (18-40 years) and in middle aged group (40-65 years) of patients scheduled for elective surgery of one upper limb distal to the shoulder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is based on biased coin design, and the concentration of LA for the next patient is determined by the result of the last one. In the case of block failure, the concentration will be increased by 0.025%. Conversely, block success will result in either a reduction in concentration by 0.025% (probability 11%) or no change in concentration (probability 89%). A blinded assistant will assess sensory and motor blockade in each nerve territory ( the median, radial, ulnar and musculocutaneous nerves) at 10-min intervals up to 30 min after completion of the block. Finally, MEC90 is calculated by isotonic regression.

Study Type

Interventional

Enrollment (Actual)

102

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

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. age between 18 and 65 years
  2. ASA 1-3
  3. body mass index between 18 and 35kg/m2

Exclusion Criteria:

  1. inability to consent to the study
  2. pregnancy
  3. allergy to local anesthetics
  4. preexisting neuropathy or coagulopathy
  5. prior surgery in the supraclavicular region

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: middle aged group
brachial plexus block with ropivacaine 40ml, MEC90 for USG-SCB
Other: brachial plexus block
brachial plexus block with ropivacaine 40ml
Other Names:
  • ultrasound guided supraclavicular block
Active Comparator: young group
brachial plexus block with ropivacaine 40ml, MEC90 for USG-SCB
Other: brachial plexus block
brachial plexus block with ropivacaine 40ml
Other Names:
  • ultrasound guided supraclavicular block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Minimum Effective Concentration of Ropivacaine in Ultrasound-guided Supraclavicular Block
Time Frame: up to 6 months
The Minimum Effective Concentration (MEC) of Ropivacaine in Ultrasound-guided Supraclavicular Block is based on 60 measurements in 60 patients (secondary outcome measure: block success). MEC is determined by biased coin design method when all patients have been tested in the study.
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Block success
Time Frame: up to 30 minutes after nerve block is performed
A blinded Assistant assess the sensory and motor block onset time for each nerve (median, radial, ulnar and musculocutaneous) at 10-min intervals up to 30 min after completion of the block.
up to 30 minutes after nerve block is performed

Collaborators and Investigators

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

Sponsor

Huazhong University of Science and Technology

Investigators

  • Study Chair: Ailin Luo, MD.,PhD, Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

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

October 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

November 2, 2014

First Submitted That Met QC Criteria

November 5, 2014

First Posted (Estimate)

November 7, 2014

Study Record Updates

Last Update Posted (Estimate)

July 28, 2015

Last Update Submitted That Met QC Criteria

July 25, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014-64

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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