MEV for Retroclavicular Approach to Infraclavicular Block

Minimum Effective Volume of Bupivacaine for Retroclavicular Approach Brachial Plexus Block

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.

Study Overview

• Status: Terminated
• Conditions: Bupivacaine
• Intervention / Treatment: Other: minimum effective volume

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.

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey
    • Antalya Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adults between 18 and 65 years of age with infraclavicular brachial lexus block for elective elbow, forearm, wrist, or hand surgery , were selected in the study.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The minimum effective volume of bupivacaine 0.5% resulting in successful block in 90% of patients (MEV90)	The determination of MEV90 and its 95% confidence interval (CI) will be based on a "biased coin up-and-down sequential design	30 minutes

Collaborators and Investigators

• Sponsor: Antalya Training and Research Hospital
• Investigators: Study Director: Ali Sait Kavakli, MD, Antalya Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: June 1, 2018
• First Submitted That Met QC Criteria: June 1, 2018
• First Posted (Actual): June 14, 2018

Study Record Updates

• Last Update Posted (Actual): April 30, 2020
• Last Update Submitted That Met QC Criteria: April 28, 2020
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: AntalyaTRH25

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No