NCT00900913

Brief Summary

The purpose of this study is to compare the effect of intravenous ropivacaine and lidocaine on the receptive field of primary sensory afferents and their influence on the vascular bed. \*Trial with medicinal product

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P50-P75 for phase_4 healthy-volunteers

Timeline
Completed

Started Jan 2010

Typical duration for phase_4 healthy-volunteers

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2008

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 13, 2009

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

August 8, 2011

Status Verified

August 1, 2011

Enrollment Period

1.3 years

First QC Date

October 21, 2008

Last Update Submit

August 5, 2011

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Aera of flare reaction (cm2), area of primary and secondary hyperalgesia (cm2)

    1 year

Interventions

ropivacaine (Naropin)DRUG

intravenous infusion 1 mg/kg bw

Also known as: Naropin

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • Age: 18 - 65 years
  • Weight: 50-100kg
  • Height: 155-195cm
  • Signed and dated informed consent
  • Sufficient command of German language

You may not qualify if:

  • Contraindications to the class of drugs under study
  • Vulnerable subjects (intellectually or mental impaired)
  • Known hypersensitivity to class of drugs or the investigational product
  • Drug abuse
  • Known peripheral neuropathies
  • Diabetes mellitus
  • Chronic alcohol consumption
  • Congestive heart disease
  • Participants of other studies during study period
  • Smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Center

Zurich, Switzerland

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • 01 Studienregister MasterAdmins

    UniversitaetsSpital Zuerich

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 21, 2008

First Posted

May 13, 2009

Study Start

January 1, 2010

Primary Completion

May 1, 2011

Study Completion

July 1, 2011

Last Updated

August 8, 2011

Record last verified: 2011-08

Locations

CH(1)