Rapydan Topical Anaesthesia for Arterial Cannulation

NCT01494311 | Completed Phase 4 DMC

• 1 other identifier: 2010/1046
• Study Type: interventional
• Target: 90
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Arterial Catheterization

Keywords

Arterial catheter; arterial cannula; Rapydan; lidocaine/tetracaine patch; topical anaesthesia

Outcome Measures

Primary Outcomes (1)

• Pain during arterial catheterization

  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.

  During and minutes after arterial cannula insertion, day 1.

Secondary Outcomes (7)

• Pain during annethetic/saline injection.

  During and minutes after injection, day 1.

• Blood concentration of plasma tetracaine

  Minutes before and after patch application, day 1.

• Patient Satisfaction

  At conclusion of procedure, day 1.

• Investigator's evaluatuion of pain during catheter insertion

  At conclusion of procedure, day 1.

• Difficulty of puncture

  During catheter insertion, day 1.

Study Arms (2)

Placebo patch and lidocaine injection

ACTIVE COMPARATOR

Fourty-five patients were randomly assigned to receive a placebo patch, looking identically to the Rapydan patch and subsequent subcutaneous injection of 0.5 ml of lidocaine 1%.

Drug: Placebo Patch; Drug: Subcutaneous injection of 0.5 ml Lidocain 1%

Lidocaine/tetracaine patch

EXPERIMENTAL

Fourty-five patients were randomly assigned to receive a lidocaine/tetracaine patch, followed by subcutaneous injection 0.5 ml of normal saline solution.

Drug: Lidocaine/tetracaine patch; Drug: Subcutaneous injection of saline

Interventions

Lidocaine/tetracaine patch DRUG

The lidocaine/tetracaine patch topical anesthetic patch contains 70 mg each of lidocaine and tetracaine. The central area of each patch consists of a Controlled Heat Assisted Drug Delivery pod which is designed to warm the skin to 26-34°C, theoretically enhancing drug absorption and allowing application just 20 minutes before percutaneous procedures. A active or placebo patch was placed on each patient's wrist in the region of the maximum radial artery pulsation. After 20 minutes, the patch was removed.

Also known as: Rapydan, Synera, 76667213

Lidocaine/tetracaine patch

Placebo Patch DRUG

A placebo patch was placed on each patient's wrist in the region of the maximum radial artery pulsation. After 20 minutes, the patch was removed.

Placebo patch and lidocaine injection

Subcutaneous injection of 0.5 ml Lidocain 1% DRUG

After removing the patch, a blinded investigator injected 0.5 ml of 1% lidocaine solution. Three minutes after injection, an attempt was made to cannulate the radial artery with a 20-gauge catheter.

Placebo patch and lidocaine injection

Subcutaneous injection of saline DRUG

After removing the patch, a blinded investigator injected 0.5 ml saline solution. Three minutes after injection, an attempt was made to cannulate the radial artery with a 20-gauge catheter.

Lidocaine/tetracaine patch

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients having elective valve-replacement or coronary artery bypass grafting requiring arterial access before induction of anaesthesia.

You may not qualify if:

• analgesic use within 24 hours before surgery
• injury or infection at the planned puncture site
• known allergy to local anesthetics
• drug abuse
• alcoholism or psychiatric disorders
• childbearing potential without adequate birth control
• abnormal Allen's test

Sponsors & Collaborators

• Medical University of Vienna: lead
• The Cleveland Clinic: collaborator
• Population Health Research Institute: collaborator

Study Sites (3)

Cleveland Clinic Department of Outcomes Research

Cleveland, Ohio, 44195, United States

Location

Medical University of Vienna

Vienna, Austria

Location

Population Health Research Institute, McMaster University

Hamilton, Ontario, Canada

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: December 16, 2011
• Study Start: March 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 18, 2013

Record last verified: 2013-03

Locations

CA (1); US (1); AU (1)