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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02512471

Enrollment

114

Registered

2015-07-31

Start date

2015-05-31

Completion date

2015-10-31

Last updated

2016-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Supraclavicular Brachial Plexus Block

Keywords

minimum effective volume, ropivacaine, ultrasound-guided supraclavicular block

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.

Interventions

DRUGRopivacaine

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)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
The Minimum Effective Volume of Ropivacaine in Ultrasound-guided Supraclavicular Block	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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026