NCT02512471

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 31, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

February 19, 2016

Status Verified

February 1, 2016

Enrollment Period

4 months

First QC Date

July 25, 2015

Last Update Submit

February 18, 2016

Conditions

Supraclavicular Brachial Plexus Block

Keywords

minimum effective volumeropivacaineultrasound-guided supraclavicular block

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

middle aged group

EXPERIMENTAL

brachial plexus block with ropivacaine 0.275%, MEV90 for USG-SCB

Drug: Ropivacaine

young group

ACTIVE COMPARATOR

brachial plexus block with ropivacaine 0.325%, MEV90 for USG-SCB

Drug: Ropivacaine

Interventions

RopivacaineDRUG

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)

Also known as: Naropin
middle aged groupyoung group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

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

July 25, 2015

First Posted

July 31, 2015

Study Start

May 1, 2015

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

February 19, 2016

Record last verified: 2016-02

Locations

CN(1)