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

Not Applicable

Completed

• Conditions: Supraclavicular Brachial Plexus Block
• Interventions: Drug: Ropivacaine

• Registration Number: NCT02512471
• Lead Sponsor: Huazhong University of Science and Technology

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-07-25
• Study First Submitted QC: 2015-07-30
• Study First Posted: 2015-07-31
• Primary Completion: 2015-09
• Study Completion: 2015-10
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-18
• Last Update Posted: 2016-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
middle aged group	Ropivacaine	brachial plexus block with ropivacaine 0.275%, MEV90 for USG-SCB
young group	Ropivacaine	brachial plexus block with ropivacaine 0.325%, MEV90 for USG-SCB

Primary Outcome Measures

Name	Time	Method
The Minimum Effective Volume of Ropivacaine in Ultrasound-guided Supraclavicular Block	up to 6 months	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.

Trial Locations

Locations (1)

Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China