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

Not Applicable

Completed

• Conditions: Minimum Effective Concentration of Local Anesthetic
• Interventions: Other: brachial plexus block

• Registration Number: NCT02286336
• Lead Sponsor: Huazhong University of Science and Technology

Brief Summary

The aim of this study is to determine the minimum effective concentration of local anesthetic (ropivacaine 40mL) required to produce an effective double-injection USG-SCB for surgical anesthesia in 90% of patients (MEC90) 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 concentration of LA for the next patient is determined by the result of the last one. In the case of block failure, the concentration will be increased by 0.025%. Conversely, block success will result in either a reduction in concentration by 0.025% (probability 11%) or no change in concentration (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, MEC90 is calculated by isotonic regression.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-11-02
• Study First Submitted QC: 2014-11-05
• Study First Posted: 2014-11-07
• Primary Completion: 2015-02
• Study Completion: 2015-03
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-25
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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
young group	brachial plexus block	brachial plexus block with ropivacaine 40ml, MEC90 for USG-SCB
middle aged group	brachial plexus block	brachial plexus block with ropivacaine 40ml, MEC90 for USG-SCB

Primary Outcome Measures

Name	Time	Method
The Minimum Effective Concentration of Ropivacaine in Ultrasound-guided Supraclavicular Block	up to 6 months	The Minimum Effective Concentration (MEC) of Ropivacaine in Ultrasound-guided Supraclavicular Block is based on 60 measurements in 60 patients (secondary outcome measure: block success). MEC is determined by biased coin design method when all patients have been tested in the study.

Secondary Outcome Measures

Name	Time	Method
Block success	up to 30 minutes after nerve block is performed	A blinded Assistant assess the sensory and motor block onset time for each nerve (median, radial, ulnar and musculocutaneous) at 10-min intervals up to 30 min after completion of the block.

Trial Locations

Locations (1)

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