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Influence of Rapydan on Clinical Chemistry and Hematology Measurements

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: October 3, 2008
Last Update Posted: May 18, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
There is an increasing awareness of the importance of treating procedure-related pain. Patients undergoing vascular access procedures are often afraid of needles and the discomfort associated with injections. This type of pain and/or fear can be stressful to patients. [1] For prevention of the pain associated with these procedures, the hospital is using Rapydan plasters. Rapydan consists out of two local anesthetics: lidocaine and tetracaïne. Rapydan produces topical anesthesia after an application time of 30 minutes and is used in the Martini Hospital for pain relieve by venipuncture and IV cannulation. The venous blood draining the anaesthetized skin contains a higher blood concentration of the local anesthetics than does venous blood in other parts of the body [2] Although the concentrations of the local anesthetics are low in patients with normal skin, the question is whether the presence of the local anesthetics which Rapydan contains might influence routine measurements in clinical chemistry and hematology.

Condition Intervention
Healthy Drug: Rapydan

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Does Rapydan Influence Routine Clinical Chemistry and Hematology Measurements?

Resource links provided by NLM:

Further study details as provided by LabNoord:

Primary Outcome Measures:
  • Routine Clinical Chemistry measurements differences [ Time Frame: 1 ]

Estimated Enrollment: 25
Study Start Date: November 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Internal control. Blood from both arms will be drawn. Only one arm of the subject is treated with Rapydan.
Drug: Rapydan
lidocaine / tetracaine 70/70 mg patch
Other Name: Lidocaine Tetracaine Patch


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Volunteers 20-60 years who are decision making competent

Exclusion Criteria:

Patients with local anesthetic allergy Patients using antiarrhythmic drugs Patients using other local anesthetics

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00765934

Groningen, Netherlands
Sponsors and Collaborators
Study Director: Rob Oude Elferink, MSc LabNoord
  More Information

Responsible Party: R.F.M. Oude Elferink, LabNoord
ClinicalTrials.gov Identifier: NCT00765934     History of Changes
Other Study ID Numbers: RapydanClinicalChemistry
First Submitted: October 2, 2008
First Posted: October 3, 2008
Last Update Posted: May 18, 2010
Last Verified: May 2010

Keywords provided by LabNoord:

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action