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MEV for Retroclavicular Approach to Infraclavicular Block

Terminated
Conditions
Bupivacaine
Registration Number
NCT03555786
Lead Sponsor
Antalya Training and Research Hospital
Brief 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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
45
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The minimum effective volume of bupivacaine 0.5% resulting in successful block in 90% of patients (MEV90)30 minutes

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Antalya Training and Research Hospital

🇹🇷

Antalya, Turkey

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