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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02286336

Enrollment

102

Registered

2014-11-07

Start date

2014-10-31

Completion date

2015-03-31

Last updated

2015-07-28

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

Conditions

Minimum Effective Concentration of Local Anesthetic

Keywords

minimum effective concentration, ropivacaine, ultrasound-guided supraclavicular block

Brief summary

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.

Detailed description

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.

Interventions

OTHERbrachial plexus block

brachial plexus block with ropivacaine 40ml

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 Concentration of Ropivacaine in Ultrasound-guided Supraclavicular Block	up to 6 months	The Minimum Effective Concentration (MEC) of Ropivacaine in Ultrasound-guided Supraclavicular Block is based on 60 measurements in 60 patients (secondary outcome measure: block success). MEC is determined by biased coin design method when all patients have been tested in the study.

Secondary

Measure	Time frame	Description
Block success	up to 30 minutes after nerve block is performed	A blinded Assistant assess the sensory and motor block onset time for each nerve (median, radial, ulnar and musculocutaneous) at 10-min intervals up to 30 min after completion of the block.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026