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
| Type | Name | Description |
|---|---|---|
| OTHER | minimum effective volume | The 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.