Healthy VolunteersPhase 4NCT00900913
Effect of Systemic Ropivacaine on Hyperalgesia, Flare Reaction and Peripheral Nerve Excitability
A Phase 4 study testing ropivacaine (Naropin) in people with Healthy Volunteers, run by University of Zurich at 1 site in Switzerland.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ropivacaine (Naropin)
- Type of treatment
- Injection or infusion
- How many people
- 34 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2010to Jul 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male
- Age: 18 - 65 years
- Weight: 50-100kg
- Height: 155-195cm
- Signed and dated informed consent
- Sufficient command of German language
Who cannot join
- 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
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- Chronic alcohol consumption
- Congestive heart disease
- Participants of other studies during study period
- Smoker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Systemic Ropivacaine on Hyperalgesia, Flare Reaction and Peripheral
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
- Conditions
- Healthy Volunteers
- Being tested
- ropivacaine (Naropin)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaine (Naropin)Drug
Also called Naropin
intravenous infusion 1 mg/kg bw
What is being measured
The primary outcome is the main question the study is designed to answer.
Aera of flare reaction (cm2), area of primary and secondary hyperalgesia (cm2)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startJan 2010
- Primary completionMay 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900913
- Sponsor's protocol ID
- StV 24-2008
- Status last verified
- Aug 2011
- First submitted
- 21 Oct 2008
- Last updated
- 8 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Systemic Ropivacaine on Hyperalgesia, Flare Reaction and Peripheral
- ClinicalTrials.gov ID
- NCT00900913
- Acronym / sponsor ID
- StV 24-2008
- Conditions
- Healthy Volunteers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 13 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male
- Age: 18 - 65 years
- Weight: 50-100kg
- Height: 155-195cm
- Signed and dated informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ropivacaine (Naropin)Also: Naropinintravenous infusion 1 mg/kg bw | Drug | – |
Primary outcome
Aera of flare reaction (cm2), area of primary and secondary hyperalgesia (cm2)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2011.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ropivacaine (Naropin) in people with Healthy Volunteers, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aera of flare reaction (cm2), area of primary and secondary hyperalgesia (cm2) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2011.