Retroclavicular Approach to Infraclavicular Block

Antalya Training and Research Hospital25 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Bupivacaine

Interventions

minimum effective volumeOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Antalya Training and Research hospital

Antalya, Turkey (Türkiye)

Outcomes

Primary Outcomes

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

Time frame: 30 minutes

Secondary Outcomes

estimate the minimum effective volume in 95% of patients (MEV95).

To calculate the MEV95, data were analyzed using probit transformation and logistic regression.

Time frame: 30 minutes

Data from ClinicalTrials.gov

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