The Minimum Effective Volume of Ropivacaine in Ultrasound-guided Supraclavicular Block

Supraclavicular Brachial Plexus Block Clinical Trial

Official title:

The Minimum Effective Volume of Ropivacaine in Ultrasound-guided Supraclavicular Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02512471
• Other study ID #: 2014-64-2
• Status: Completed
• Phase: N/A
• First received: July 25, 2015
• Last updated: February 18, 2016
• Start date: May 2015
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to determine the minimum effective volume of local anesthetic (ropivacaine 0.275% and 0.325%) required to produce an effective double-injection USG-SCB for surgical anesthesia in 90% of patients (MEV90) in young group (18-40 years) and in middle aged group (40-65 years) of patients scheduled for elective surgery of one upper limb distal to the shoulder.

Description:

The study is based on biased coin design, and the volume of LA for the next patient is determined by the result of the last one. In the case of block failure, the volume will be increased by 2ml. Conversely, block success will result in either a reduction in volume by 2ml (probability 11%) or no change in volume (probability 89%). A blinded assistant will assess sensory and motor blockade in each nerve territory ( the median, radial, ulnar and musculocutaneous nerves) at 10-min intervals up to 30 min after completion of the block. Finally, MEV90 is calculated by isotonic regression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. age between 18 and 65 years

2. ASA 1-3

3. body mass index between 18 and 35kg/m2

Exclusion Criteria:

1. inability to consent to the study

2. pregnancy

3. allergy to local anesthetics

4. preexisting neuropathy or coagulopathy

5. prior surgery in the supraclavicular region

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Supraclavicular Brachial Plexus Block

Intervention

Drug:
• Ropivacaine
brachial plexus block with ropivacaine 0.275%, MEV90 for USG-SCB (young group) brachial plexus block with ropivacaine 0.325%, MEV90 for USG-SCB (middle-aged group)

Locations

Country	Name	City	State
China	Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Minimum Effective Volume of Ropivacaine in Ultrasound-guided Supraclavicular Block	The Minimum Effective Volume (MEV) of Ropivacaine in Ultrasound-guided Supraclavicular Block is based on 55 measurements in 55 patients (secondary outcome measure: block success). MEV is determined by biased coin design method when all patients have been tested in the study.	up to 6 months	No