Retroclavicular Approach to Infraclavicular Block

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-08

Study Completion Date

2018-03-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bupivacaine

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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minimum effective volume

The determination of MEV50 and its 95% confidence interval (CI) was based on the staircase up-and-down method by Dixon and Massey.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients who received infraclavicular brachial plexus block for elective elbow, forearm, wrist, or hand surgery
* American Society of Anesthesiologists class I, II or III

Exclusion Criteria

* patients \<18 years old
* \>65 years old
* body mass index (BMI) \<20 or \>35 kg/m2
* inability to provide written informed consent
* refusal of regional anesthesia
* pregnancy
* contraindication for regional anesthesia

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No