Analgesic effect of lidocaine/propitocaine eutectic mixture patch

JRCT ID: jRCT1041240045

Registered date:13/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Not applicable (healthy adult)
• Date of first enrollment: 13/06/2024
• Target sample size: 190
• Study type: Interventional

Intervention(s)

Trial 1
Group A : Venipuncture using a 24G indwelling needle after 30 minutes of penless tape application.
Group B : Venipuncture using a 22G indwelling needle after 30 minutes of penless tape application.
Group C : Venipuncture with 24G indwelling needle after 60 minutes of application of EMLA patch.
Group D : Venipuncture with 22G indwelling needle after 60 minutes of application of EMLA patch.

Trial 2
Group A : Venipuncture with 24G indwelling needle after 60 minutes of application of EMLA patch.
Group B : Venipuncture with 22G indwelling needle after 60 minutes of application of EMLA patch.
Group C : Venipuncture with 24G indwelling needle after 90 minutes of application of EMLA patch.
Group D : Venipuncture with 22G indwelling needle after 90 minutes of application of EMLA patch.
Group E : Venipuncture with 24G indwelling needle after 120 minutes of application of EMLA patch.
Group F : Venipuncture with 22G indwelling needle after 120 minutes of application of EMLA patch.

Outcome(s)

Primary Outcome

1) Pain assessment using a visual analogue scale
2) Pain assessment using a verbal rating score
3) Pain assessment using current perception threshold

Secondary Outcome

1) Pulse rate
2) Blood pressure
3) SpO2
4) ECG Waveform
5) Frequency, rate and severity of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 45age old
• Gender: Male

Include criteria

1) Healthy individuals (equivalent to ASA-PS class 1,2)
2) Sex: male
3) Age: between 18 and 45 years old
4) Those who voluntarily provided written informed consent upon receiving sufficient explanation and understanding the content of the study

Exclude criteria

1) Persons with a history of drug allergies.
2) Persons with a history of contact dermatitis in response to topical medication.
3) Persons with or a history of severe liver disease, kidney disease, circulatory disease.
4) Persons whose veins are difficult to identify on the dorsum of the hand, forearm, elbow fossa, or upper arm.
5) Subjects with skin abnormalities (eczema, dermatitis, scars, etc.) that may affect observation of the study drug application site.
6) Persons with Methemoglobinemia.
7) Persons with sensory paralysis in the limbs.
8) Persons who plan to use all drugs except the study drug form the day before the test drug is applied until the end of efficacy evalution.
9) Persons who have already participated in a study of the study drug and have been administered this study drug.
10) Persons who have participated in other research and received the study drug within 120 days of application of the study drug.
11) In addition, persons who are judged by the research-responsible doctor to be inappropriate as subjects.

Related Information

• Primary Sponsor: Goto Takashi