Rapydan Topical Anaesthesia for Arterial Cannulation

NCT ID: NCT01494311

Last Updated: 2013-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2011-10-31

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.

Detailed Description

Many clinical procedures including arterial and venous punctures, percutaneous venous catheter insertion, lumbar puncture, and dermatological procedures are associated with pain and consequent patient discomfort.1-2 With the exception of venopuncture, arterial puncture is the most common invasive procedure performed on critically ill patients. Also, it is often necessary before induction of anaesthesia for invasive measurements of blood pressure and collection of arterial blood samples in patients undergoing major cardiac surgery. Injection of local anesthetics before insertion causes intra-dermal turgor and can trigger local vasoconstriction, both of which reduce puncture success rate.

An alternative approach is to use topical anesthesia for percutaneous procedures. However, intact skin presents a significant barrier to topical anesthetic preparations. Therefore, topical anesthetic preparations typically must be applied under occlusive dressings for 45-60 minutes before vascular access - which is often longer than is clinically practical.

Rapydan (also known as Synera in the United States) is a novel topical anesthetic patch that contains 70 mg each of lidocaine and tetracaine. The central area of each Rapydan patch consists of a Controlled Heat Assisted Drug Delivery pod which is designed to allow for application just 20 minutes before percutaneous procedures. However, the efficacy of Rapydan topical analgesia has yet to be quantified for the more intense pain resulting from arterial puncture. We thus compared routine analgesia (subcutaneous injection with 0.5 ml of 1% lidocaine) with heated lidocaine/tetracaine patches. Specifically, we tested the hypothesis that lidocaine/tetracaine patch analgesia is non-inferior to that provided by subcutaneous lidocaine injection for insertion of arterial catheters.

Ninty patients undergoing elective major cardiac surgery were included in this prospective, double blind clinical trial. Patients were randomly assigned to receive either a lidocaine/tetracaine patch, followed by subcutaneous injection 0.5 ml of normal saline solution or placebo patch, looking identically to the Rapydan patch and subsequent subcutaneous injection of 0.5 ml of lidocaine 1%. Pain during arterial catheterization using 100-mm-long visual analog scale (VAS) was the primary outcome. Other outcomes were pain during anesthetic/saline injection and plasma tetracaine concentrations.

VAS pain scores during arterial puncture were comparable in both groups and Rapydan was non-inferior to subcutaneous lidocaine. Pain scores at the time of subcutaneous injection were significantly lower (better) in patients assigned to the lidocaine/tetracaine patch than to lidocaine (P = 0.001). Plasma tetracaine concentrations never exceeded the detection limit of 25 ng/ml at any time in any patient.

Both the lidocaine/tetracaine patch and subcutaneous injection of lidocaine provided comparable pain control during arterial catheter insertion. Subcutaneous lidocaine caused discomfort during injection whereas the lidocaine/tetracaine patch required placement 20 minutes before the procedure. Given adequate time, the patch provided better overall analgesia by obviating the need for subcutaneous infiltration.

Conditions

Arterial Catheterization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Placebo patch and lidocaine injection

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%.

Group Type: ACTIVE_COMPARATOR

Placebo Patch

Intervention Type: 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.

Subcutaneous injection of 0.5 ml Lidocain 1%

Intervention Type: 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.

Lidocaine/tetracaine patch

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

Group Type: EXPERIMENTAL

Lidocaine/tetracaine patch

Intervention Type: 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.

Subcutaneous injection of saline

Intervention Type: 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.

Interventions

Lidocaine/tetracaine patch

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.

Intervention Type: DRUG

Placebo Patch

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.

Intervention Type: DRUG

Subcutaneous injection of 0.5 ml Lidocain 1%

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.

Intervention Type: DRUG

Subcutaneous injection of saline

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.

Intervention Type: DRUG

Other Intervention Names

Rapydan; Synera, 76667213

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

Population Health Research Institute

OTHER

Sponsor Role: collaborator

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Kurt Rutzler

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cleveland Clinic Department of Outcomes Research

Cleveland, Ohio, United States

Medical University of Vienna

Vienna, , Austria

Population Health Research Institute, McMaster University

Hamilton, Ontario, Canada

Countries

United States; Austria; Canada

Other Identifiers

2010/1046

Identifier Type: -

Identifier Source: org_study_id