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

NCT02286336 | Completed

• 1 other identifier: 2014-64
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Minimum Effective Concentration of Local Anesthetic

Keywords

minimum effective concentration; ropivacaine; ultrasound-guided supraclavicular block

Outcome Measures

Primary Outcomes (1)

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

  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.

  up to 6 months

Secondary Outcomes (1)

• Block success

  up to 30 minutes after nerve block is performed

Study Arms (2)

middle aged group

EXPERIMENTAL

brachial plexus block with ropivacaine 40ml, MEC90 for USG-SCB

Other: brachial plexus block

young group

ACTIVE COMPARATOR

brachial plexus block with ropivacaine 40ml, MEC90 for USG-SCB

Other: brachial plexus block

Interventions

brachial plexus block OTHER

brachial plexus block with ropivacaine 40ml

Also known as: ultrasound guided supraclavicular block

middle aged group; young group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 65 years
• ASA 1-3
• body mass index between 18 and 35kg/m2

You may not qualify if:

• inability to consent to the study
• pregnancy
• allergy to local anesthetics
• preexisting neuropathy or coagulopathy
• prior surgery in the supraclavicular region

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Interventions

Brachial Plexus Block

Intervention Hierarchy (Ancestors)

Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Ailin Luo, MD.,PhD

  Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 2, 2014
• First Posted: November 7, 2014
• Study Start: October 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: July 28, 2015

Record last verified: 2015-07

Locations

CN (1)