Clinical Trials Directory

Trials / Terminated

TerminatedNCT03555786

MEV for Retroclavicular Approach to Infraclavicular Block

Minimum Effective Volume of Bupivacaine for Retroclavicular Approach Brachial Plexus Block

Status
Terminated
Phase
Study type
Observational
Enrollment
45 (actual)
Sponsor
Antalya Training and Research Hospital · Other Government
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

In this study, the primary objective was to estimate the minimum effective volume of bupivacaine 0.5% resulting in successful block in 90% of patients (MEV90) for ultrasound-guided retroclavicular approach to infraclavicular brachial plexus block.

Detailed description

A "biased coin up-and-down sequential design" will be applied to assess the minimum effective volume in 90% of patients for the retroclavicular brachial plexus block. The first subject received 25 ml 0.5% bupivacaine . Each subsequent patient received a dose that depended on the response of the previous one. If the previous block is successful, the block will be performed either by a reduction of the volume by 2.5 ml with a probability ß = 0.11 or by a same dose of the previous one with a probability 1-ß = 0.89 in the next patient.

Conditions

Interventions

TypeNameDescription
OTHERminimum effective volumeThe determination of MEV90 and its 95% confidence interval (CI) will be based on a "biased coin up-and-down sequential design

Timeline

Start date
2018-06-01
Primary completion
2018-08-01
Completion
2018-09-01
First posted
2018-06-14
Last updated
2020-04-30

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT03555786. Inclusion in this directory is not an endorsement.