Retroclavicular Approach to Infraclavicular Block

Minimum Effective Volume of Bupivacaine 0.5% for Ultrasound-guided Retroclavicular Approach to Infraclavicular 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 50% of patients (MEV50) for ultrasound-guided retroclavicular approach to infraclavicular brachial plexus block.

Study Overview

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

Detailed Description

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 (Actual): 25

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey, 07100
    • Antalya Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 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?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

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 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	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
estimate the minimum effective volume in 95% of patients (MEV95).	To calculate the MEV95, data were analyzed using probit transformation and logistic regression.	30 minutes

Collaborators and Investigators

• Sponsor: Antalya Training and Research Hospital
• Investigators: Study Director: Ali Sait Kavakli, M.D., Antalya Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2018
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 15, 2018

Study Registration Dates

• First Submitted: March 15, 2018
• First Submitted That Met QC Criteria: March 15, 2018
• First Posted (Actual): March 21, 2018

Study Record Updates

• Last Update Posted (Actual): May 3, 2018
• Last Update Submitted That Met QC Criteria: May 2, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: AntalyaTRH 20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No