MEV for Retroclavicular Approach to Infraclavicular Block

Bupivacaine Clinical Trial

Official title:

Minimum Effective Volume of Bupivacaine for Retroclavicular Approach Brachial Plexus Block

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03555786
• Other study ID #: AntalyaTRH25
• Status: Terminated
• Start date: June 1, 2018
• Est. completion date: September 1, 2018

Study information

• Verified date: November 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 90% of patients (MEV90) for ultrasound-guided retroclavicular approach to infraclavicular brachial plexus block.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: September 1, 2018
• Est. primary completion date: August 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 MEV90 and its 95% confidence interval (CI) will be based on a "biased coin up-and-down sequential design

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 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