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

H

Huazhong University of Science and Technology

Status

Completed

Conditions

Supraclavicular Brachial Plexus Block

Treatments

Drug: Ropivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02512471
2014-64-2

Details and patient eligibility

About

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.

Full 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.

Enrollment

114 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

114 participants in 2 patient groups

middle aged group
Experimental group
Description:
brachial plexus block with ropivacaine 0.275%, MEV90 for USG-SCB
Treatment:
Drug: Ropivacaine
young group
Active Comparator group
Description:
brachial plexus block with ropivacaine 0.325%, MEV90 for USG-SCB
Treatment:
Drug: Ropivacaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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