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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Minimum Effective Concentration of Local Anesthetic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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middle aged group

brachial plexus block with ropivacaine 40ml, MEC90 for USG-SCB

Group Type EXPERIMENTAL

brachial plexus block

Intervention Type OTHER

brachial plexus block with ropivacaine 40ml

young group

brachial plexus block with ropivacaine 40ml, MEC90 for USG-SCB

Group Type ACTIVE_COMPARATOR

brachial plexus block

Intervention Type OTHER

brachial plexus block with ropivacaine 40ml

Interventions

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brachial plexus block

brachial plexus block with ropivacaine 40ml

Intervention Type OTHER

Other Intervention Names

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ultrasound guided supraclavicular block

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No