Retroclavicular Approach to Infraclavicular Block

Completed

• Conditions: Bupivacaine

• Registration Number: NCT03472911
• Lead Sponsor: Antalya Training and Research Hospital

Brief Summary

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.

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 Timeline

• Status Verified: 2018-01
• Study Start: 2018-01-08
• Primary Completion: 2018-03-01
• Study Completion: 2018-03-15
• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-03-15
• Study First Posted: 2018-03-21
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The minimum effective volume of bupivacaine 0.5% resulting in successful block in 50% of patients (MEV50)	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 Outcome Measures

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

Trial Locations

Locations (1)

Antalya Training and Research hospital; 🇹🇷 Antalya, Turkey