Retroclavicular Approach to Infraclavicular Block

Bupivacaine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03472911
• Other study ID #: AntalyaTRH 20
• Status: Completed
• Start date: January 8, 2018
• Est. completion date: March 15, 2018

Study information

• Verified date: January 2018
• Source: Antalya Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 15, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bupivacaine

Intervention

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

Locations

Country	Name	City	State
Turkey	Antalya Training and Research hospital	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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