Skip to main content
OpenTrials
Completed

NCT Number: NCT02512471

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Supraclavicular Brachial Plexus Block

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Ropivacaine

Drug

brachial plexus block with ropivacaine 0.275%, MEV90 for USG-SCB (young group) brachial plexus block with ropivacaine 0.325%, MEV90 for USG-SCB (middle-aged group)

Other names: Naropin

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 31, 2015
Registry last updated
Feb 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.