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In this study, the primary objective was to estimate the minimum effective volume of bupivacaine 0.5% resulting in successful block in 50% of patients (MEV50) for ultrasound-guided retroclavicular approach to infraclavicular brachial plexus block.
Two rules were used to stop the study. First stopping rule was a fixed-sample-size. The investigators used an up-and-down method to estimate the threshold for an all-or-none response for present study design. Therefore, for sample size calculation, the investigators applied the formula by Dixon and Massey, n=2(SD/SEM)2 (SD: standard deviation and SEM: standard error of mean). Second stopping rule included demonstration of minimum of five consecutive up-and-down sequences. On the basis of previous studies with similar binary outcomes, the investigators estimated that a priori a minimum of five negative-positive up-and down deflections was required to calculate MEV50.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| minimum effective volume | Other | The determination of MEV50 and its 95% confidence interval (CI) was based on the staircase up-and-down method by Dixon and Massey. |
| Measure | Description | Time Frame |
|---|---|---|
| The minimum effective volume of bupivacaine 0.5% resulting in successful block in 50% of patients (MEV50) | The determination of MEV50 and its 95% confidence interval (CI) was based on the staircase up-and-down method by Dixon and Massey | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| estimate the minimum effective volume in 95% of patients (MEV95). | To calculate the MEV95, data were analyzed using probit transformation and logistic regression. | 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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Adults between 18 and 65 years of age with infraclavicular brachial lexus block for elective elbow, forearm, wrist, or hand surgery , were selected in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Ali Sait Kavakli, M.D. | Antalya Training and Research Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antalya Training and Research hospital | Antalya | 07100 | Turkey (Türkiye) |
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