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MEV for Retroclavicular Approach to Infraclavicular Block

Minimum Effective Volume of Bupivacaine for Retroclavicular Approach Brachial Plexus Block

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03555786
Enrollment
45
Registered
2018-06-14
Start date
2018-06-01
Completion date
2018-09-01
Last updated
2020-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bupivacaine

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.

Interventions

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

Sponsors

Antalya Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The minimum effective volume of bupivacaine 0.5% resulting in successful block in 90% of patients (MEV90)30 minutesThe determination of MEV90 and its 95% confidence interval (CI) will be based on a biased coin up-and-down sequential design

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026