Skip to main content
OpenTrials
Completed

NCT Number: NCT03472911

Retroclavicular Approach to Infraclavicular Block

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bupivacaine

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Antalya Training and Research hospital

Antalya, 07100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. The minimum effective volume of bupivacaine 0.5% resulting in successful block in 50% of patients (MEV50)

    Time frame: 30 minutes

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

Secondary outcomes

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

    Time frame: 30 minutes

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

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Registry information

Official study title

Minimum Effective Volume of Bupivacaine 0.5% for Ultrasound-guided Retroclavicular Approach to Infraclavicular Brachial Plexus Block

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 21, 2018
Registry last updated
May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.