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NCT01494311 · ClinicalTrials.gov registry record · Phase 4

Rapydan Topical Anaesthesia for Arterial Cannulation

A Phase 4 study, sponsored by Medical University of Vienna.

Completed
Registry status
Phase 4
Development phase
90
Enrollment target

NCT01494311: Completed Phase 4 study, sponsored by Medical University of Vienna.

NCT01494311 is a Phase 4 study that has completed, run by Medical University of Vienna. The registered enrollment target is 90 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01494311, a Phase 4 study, has completed, sponsored by Medical University of Vienna.

COMPLETED
Registry status
Phase 4
Development phase
90 participants
Enrollment target

Study Summary

Arterial catheterization is painful and is associated with patient stress and anxiety. Analgesia is usually provided by subcutaneous injection of local anesthetic. An alternative is topical anaesthesia, such as Rapydan which is a novel topical anesthetic patch containing 70 mg each of lidocaine and tetracaine. We therefore tested the hypothesis that Rapydan patch analgesia is non-inferior to subcutaneous local anesthetic.

Primary Outcome

After finishing the puncture procedure, patients were asked to rate their worst pain during subcutaneous injection, during insertion of arterial cannula, and one minute after catheter insertion using a 100-mm-long visual analog scale (VAS). The use of a VAS to measure pain and discomfort has been validated in the several settings of chronic pain, acute postoperative pain, and acute non-surgical pain.

Interventions

  • DRUG Placebo Patch
  • DRUG Lidocaine/tetracaine patch
  • DRUG Subcutaneous injection of 0.5 ml Lidocain 1%
  • DRUG Subcutaneous injection of saline

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2011-03
Est. Completion 2011-10
Phase Phase 4
Medical University of Vienna

3 total trials

What the finished NCT01494311 record still lists

NCT01494311 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 4 interventions - of which Placebo Patch is the first listed.

NCT01494311 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01494311 about?

NCT01494311 is a clinical study titled "Rapydan Topical Anaesthesia for Arterial Cannulation". Arterial catheterization is painful and is associated with patient stress and anxiety. Analgesia is usually provided by subcutaneous injection of local anesthetic. An alternative is topical anaesthesia, such as Rapydan which is a novel topical anesthetic patch containing 70 mg each of lidocaine and ...

What is the current status of trial NCT01494311?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 90 participants. The study started on 2011-03. Estimated completion is 2011-10.

What interventions are being tested in trial NCT01494311?

The interventions under investigation include: Placebo Patch (DRUG), Lidocaine/tetracaine patch (DRUG), Subcutaneous injection of 0.5 ml Lidocain 1% (DRUG), Subcutaneous injection of saline (DRUG).

Who is sponsoring clinical trial NCT01494311?

This trial is sponsored by Medical University of Vienna, which has 3 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01494311's enrollment target sits among peer trials

90 886th of 2000 higher than 1,088 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01494311, the US trial registry maintained by the National Library of Medicine. NCT01494311 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.