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Clinical Trials/NCT02512471
NCT02512471
Completed
Not Applicable

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

Huazhong University of Science and Technology1 site in 1 country114 target enrollmentMay 2015

Overview

Phase
Not Applicable
Intervention
Ropivacaine
Conditions
Supraclavicular Brachial Plexus Block
Sponsor
Huazhong University of Science and Technology
Enrollment
114
Locations
1
Primary Endpoint
The Minimum Effective Volume of Ropivacaine in Ultrasound-guided Supraclavicular Block
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The aim of this study is to determine the minimum effective volume of local anesthetic (ropivacaine 0.275% and 0.325%) required to produce an effective double-injection USG-SCB for surgical anesthesia in 90% of patients (MEV90) 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.

Detailed Description

The study is based on biased coin design, and the volume of LA for the next patient is determined by the result of the last one. In the case of block failure, the volume will be increased by 2ml. Conversely, block success will result in either a reduction in volume by 2ml (probability 11%) or no change in volume (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, MEV90 is calculated by isotonic regression.

Registry
clinicaltrials.gov
Start Date
May 2015
End Date
October 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fang Gang

Dr.

Huazhong University of Science and Technology

Eligibility Criteria

Inclusion Criteria

  • age between 18 and 65 years
  • body mass index between 18 and 35kg/m2

Exclusion Criteria

  • inability to consent to the study
  • allergy to local anesthetics
  • preexisting neuropathy or coagulopathy
  • prior surgery in the supraclavicular region

Arms & Interventions

middle aged group

brachial plexus block with ropivacaine 0.275%, MEV90 for USG-SCB

Intervention: Ropivacaine

young group

brachial plexus block with ropivacaine 0.325%, MEV90 for USG-SCB

Intervention: Ropivacaine

Outcomes

Primary Outcomes

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

Time Frame: up to 6 months

The Minimum Effective Volume (MEV) of Ropivacaine in Ultrasound-guided Supraclavicular Block is based on 55 measurements in 55 patients (secondary outcome measure: block success). MEV is determined by biased coin design method when all patients have been tested in the study.

Study Sites (1)

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