Radial Artery SpasmPhase 4NCT03501212
Effect of Topical Anesthesia on Patient's Pain Discomfort and Radial Artery Spasm in Transradial Catheterization
A Phase 4 study testing Topical Anesthetic in people with Radial Artery Spasm, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
Trial summary
This study evaluate topical anaesthesia application for 30 minutes before tranradial catheterization during cardiac catheterization can reduce pain and decrease radial artery spasm Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radial Artery Spasm
- What is being tested?
- Topical Anesthetic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteThailand
- Study dates
- 27 Apr 2019to 30 Jun 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age >18 years.
- Patients who was schedule to performed coronary angiogram
Who cannot join
- Previous ipsilateral transradial approach Raynaud's syndrome ESRD History of sensitivity to local anesthetics Non-palpable redial pulse Abnormal Barbeau's test Local site infection Patient's refusal
Trial locations and contacts
1 site in 1 country.
Nakarin Sansanatudh contact
Thailand1 site, 1 recruiting
- Recruiting
Department of Internal Medicine
Bangkok, 10400
Anuwat Rintaravitoon, MD, +66869920022 ext. 33334, Rintaravitoon@hotmail.com
Nakarin Sansanayudh, MD,Phd, +6623547600 ext. 93827, dr_nakarin@hotmail.com
About this study
This study evaluate topical anaesthesia application for 30 minutes before tranradial catheterization during cardiac catheterization can reduce pain and decrease radial artery spasm
Read the detailed description
The incidence of Radial artery spasm (RAS) has varied from 5-30% RAS refers to friction between the artery and wires or guide catheters accompanied by a subjective feeling of pain.
EMLA anesthetic ointment (AO-Astra Zeneca) is an emulsion of lidocaine 2.5% and prilocaine 2.5% in a ratio of 1:1 by weight Previous study showed that EMLA cream can increase the success rate of femoral cannulation in children.
- Conditions
- Radial Artery Spasm
- Being tested
- Topical Anesthetic, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical AnestheticDrug
EMLA Cream 2.5 gr applied to both wrists
PlaceboDrug
Placebo Cream 2.5gr applied to both wrist
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Active comparator | EMLA group layer of 2.5 gr EMLA cream (standard adult dose) was applied to both wrists Receives: Drug: Topical Anesthetic |
| Placebo | Placebo comparator | Placebo cream was applied to both wrists Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radial pain assessed during artery puncture
Record pain by visual analog score sub-scale 0(no pain)-10(max pain)
Measured: 30 min
Secondary outcomes (3)
Radial pain assessed 30 min after sheath removal
Record pain by visual analog score
Measured: 4 hr post procedure
Number of puncture attempts
Number of puncture attempts
Measured: imediate post procedure
Occurrence of radial artery spasm
NuNumber of radial artery spasm
Measured: during and post procedure up to 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start27 Apr 2019 (estimated)
- Primary completion27 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial Artery SpasmStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phramongkutklao College of Medicine and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501212
- Sponsor's protocol ID
- PMK-2018
- Status last verified
- Aug 2018
- First submitted
- 21 Mar 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Anesthesia on Patient's Pain Discomfort and Radial Artery Spasm in Transradial Catheterization
- ClinicalTrials.gov ID
- NCT03501212
- Acronym / sponsor ID
- PMK-2018
- Conditions
- Radial Artery Spasm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Phramongkutklao College of Medicine and HospitalUniversity, hospital or other
- Study start
- 27 Apr 2019 (estimated)
- Primary completion
- 27 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 18 Apr 2018 (actual)
- 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.
This study evaluate topical anaesthesia application for 30 minutes before tranradial catheterization during cardiac catheterization can reduce pain and decrease radial artery spasm
Detailed description
The incidence of Radial artery spasm (RAS) has varied from 5-30% RAS refers to friction between the artery and wires or guide catheters accompanied by a subjective feeling of pain.
EMLA anesthetic ointment (AO-Astra Zeneca) is an emulsion of lidocaine 2.5% and prilocaine 2.5% in a ratio of 1:1 by weight Previous study showed that EMLA cream can increase the success rate of femoral cannulation in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Active comparator | Drug: Topical AnestheticEMLA group layer of 2.5 gr EMLA cream (standard adult dose) was applied to both wrists |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo cream was applied to both wrists |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients age >18 years.
- Patients who was schedule to performed coronary angiogram
Key exclusion criteria (1 listed)
- Previous ipsilateral transradial approach Raynaud's syndrome ESRD History of sensitivity to local anesthetics Non-palpable redial pulse Abnormal Barbeau's test Local site infection Patient's refusal
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 |
|---|---|---|
| Topical AnestheticEMLA Cream 2.5 gr applied to both wrists | Drug | Interventional |
| PlaceboPlacebo Cream 2.5gr applied to both wrist | Drug | Placebo |
Primary outcome
Radial pain assessed during artery puncture
Time frame: 30 min
Record pain by visual analog score sub-scale 0(no pain)-10(max pain)
3 secondary outcomes
Radial pain assessed 30 min after sheath removal
Time frame: 4 hr post procedure
Number of puncture attempts
Time frame: imediate post procedure
Occurrence of radial artery spasm
Time frame: during and post procedure up to 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
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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.
Nakarin Sansanatudh contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topical Anesthetic in people with Radial Artery Spasm, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anuwat Rintaravitoon (+66869920022, Rintaravitoon@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radial pain assessed during artery puncture (time frame: 30 min). 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 29 Aug 2018.