Arterial CatheterizationPhase 4NCT01494311
Rapydan Topical Anaesthesia for Arterial Cannulation
A Phase 4 study testing Lidocaine/tetracaine patch, Subcutaneous injection of 0.5 ml Lidocain 1% and Subcutaneous injection of saline in people with Arterial Catheterization, run by Medical University of Vienna at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Arterial Catheterization
- What is being tested?
- Lidocaine/tetracaine patch, Subcutaneous injection of 0.5 ml Lidocain 1% and Subcutaneous injection of saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Mar 2011to Oct 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having elective valve-replacement or coronary artery bypass grafting requiring arterial access before induction of anaesthesia.
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
Cleveland Clinic Department of Outcomes Research
Cleveland, Ohio, 44195
Canada1 site
Population Health Research Institute, McMaster University
Hamilton, Ontario
About this study
Official title: Lidocaine/Tetracaine Patch (Rapydan) for Topical Anaesthesia Before Arterial Access: A Double-blind, Randomized Trial
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.
Read the 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
- Being tested
- Lidocaine/tetracaine patch, Placebo Patch, Subcutaneous injection of 0.5 ml Lidocain 1%, Subcutaneous injection of saline
- Keywords
- Arterial catheter, arterial cannula, Rapydan, lidocaine/tetracaine patch, topical anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine/tetracaine patchDrug
Also called Rapydan, Synera, 76667213
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.
Placebo PatchDrug
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%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.
Subcutaneous injection of salineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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%. Receives: 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. Receives: Drug: Lidocaine/tetracaine patch; Drug: Subcutaneous injection of saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During and minutes after arterial cannula insertion, day 1.
Secondary outcomes (7)
Pain during annethetic/saline injection.
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).
Measured: During and minutes after injection, day 1.
Blood concentration of plasma tetracaine
Blood for measurement of plasma tetracaine concentrations sampled: 1) before patch application; 2) 15 minutes after patch application; 3) immediately after successful arterial puncture; 4) 30 minutes after patch application; and, 5) 60 minutes after patch application. Only blood samples from patients assigned to the tetracaine/lidocaine patch were analyzed.
Measured: Minutes before and after patch application, day 1.
Patient Satisfaction
Patients also subjectively rated their procedure-related satisfaction on a four-point scale: 0 = unsatisfied; 1 = moderately satisfied; 2 = satisfied; and, 3 = very satisfied.
Measured: At conclusion of procedure, day 1.
Investigator's evaluatuion of pain during catheter insertion
Investigators who were unaware of the randomization estimated each patient's pain intensity at the time of catheter insertion on a four-point scale with 0 indicating no pain and 3 indicating severe pain.
Measured: At conclusion of procedure, day 1.
Difficulty of puncture
The difficulty of the puncture was assessed using a 5-point scale with 1 being insertion at first attempt through 5 which indicated failure to insert the catheter.
Measured: During catheter insertion, day 1.
Number of punctrue attempts
The number of puncture attempts were documented by the investigator.
Measured: During catheter insertion, day 1.
Incidence of edema and erthema at the patch site
After the patches were removed an investigator, blinded to the study randomization, evaluated the treatment sites for skin reactions including edema and erythema using a 5-point Likert scale (1 = none; 5 = vigorous).
Measured: Evaluated immediately after patch removed, day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial CatheterizationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic, Population Health Research Institute
- Responsible party
- Principal investigator, Kurt Rutzler, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01494311
- Sponsor's protocol ID
- 2010/1046
- Status last verified
- Mar 2013
- First submitted
- 15 Dec 2011
- Last updated
- 18 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine/Tetracaine Patch (Rapydan) for Topical Anaesthesia Before Arterial Access: A Double-blind, Randomized Trial
- ClinicalTrials.gov ID
- NCT01494311
- Acronym / sponsor ID
- 2010/1046
- Conditions
- Arterial Catheterization
- Keywords
- Arterial catheter, arterial cannula, Rapydan, lidocaine/tetracaine patch, topical anaesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- The Cleveland Clinic, Population Health Research Institute
- Study start
- Mar 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 16 Dec 2011 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo patch and lidocaine injection | Active comparator | Drug: Placebo Patch, Drug: Subcutaneous injection of 0.5 ml Lidocain 1%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%. |
| Lidocaine/tetracaine patch | Experimental | Drug: Lidocaine/tetracaine patch, Drug: Subcutaneous injection of salineFourty-five patients were randomly assigned to receive a lidocaine/tetracaine patch, followed by subcutaneous injection 0.5 ml of normal saline solution. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients having elective valve-replacement or coronary artery bypass grafting requiring arterial access before induction of anaesthesia.
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Lidocaine/tetracaine patchAlso: Rapydan, Synera, 76667213The 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. | Drug | Lidocaine/tetracaine patch |
| Placebo PatchA 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. | Drug | Placebo patch and lidocaine injection |
| 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. | Drug | Placebo patch and lidocaine injection |
| Subcutaneous injection of salineAfter 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. | Drug | Lidocaine/tetracaine patch |
Primary outcome
Pain during arterial catheterization
Time frame: During and minutes after arterial cannula insertion, day 1.
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.
7 secondary outcomes
Pain during annethetic/saline injection.
Time frame: During and minutes after injection, day 1.
Blood concentration of plasma tetracaine
Time frame: Minutes before and after patch application, day 1.
Patient Satisfaction
Time frame: At conclusion of procedure, day 1.
Investigator's evaluatuion of pain during catheter insertion
Time frame: At conclusion of procedure, day 1.
Difficulty of puncture
Time frame: During catheter insertion, day 1.
Number of punctrue attempts
Time frame: During catheter insertion, day 1.
Incidence of edema and erthema at the patch site
Time frame: Evaluated immediately after patch removed, day 1.
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 18 Mar 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine/tetracaine patch, Subcutaneous injection of 0.5 ml Lidocain 1% and Subcutaneous injection of saline in people with Arterial Catheterization, run by Medical University of Vienna at 3 sites in 3 countries.
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 1 inclusion and 7 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 18 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Austria, Canada. 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?
Pain during arterial catheterization (time frame: During and minutes after arterial cannula insertion, day 1.). 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 18 Mar 2013.