A Comparison of the depth and onset of cutaneous anesthesia of topical 10% Lidocaine and 5% Lidocaine/Prilocaine

Phase 4

Completed

• Conditions: healthy human volunteers; Anesthesia, local, lidocaine, prilocaine, EMLA, depth, onset, duration

• Registration Number: TCTR20210521005
• Lead Sponsor: Srinakharinwirot University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-04-09
• Study Start: 2021-05-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Healthy volunteers aged 18-50 years
2. Agree to participate in a research project voluntarily. All project details will be provided and sign in writing the consent to join the project (Informed consent)

Exclusion Criteria

1. History of anesthetic allergy to Lidocaine or Prilocaine.
2. Having any underlying disease that may be affected by pain, stress and anesthesia, such as cardiovascular disease, diabetes mellitus, etc.
3. G-6-PD deficiency
4. History of keloids on the skin around the forearms
5. Have an infection or there is inflammation of the skin around the forearms
6. Skin sensitivity to tape
7. Pregnancy or breast feeding
8. Bleeding tendency
9. Cognitive impairment, severe psychiatric or psychological problems
10. Have an infectious disease that can be transmitted through blood, such as HIV infection, hepatitis B virus, etc.
11. Chronic pain
12. Fear of needles

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
onset of anesthesia at application time of 15, 30, 45, 60, 90, 120 and 150 minutes Using 22G-needle connected to the digital depth gauge inserted into skin and asked the subject to rate the pain by Verbal pain scale (VPS)

Secondary Outcome Measures

Name	Time	Method
depth of anesthesia at application time of 15, 30, 45, 60, 90, 120 and 150 minutes Using 22G-needle connected to the digital depth gauge inserted into skin and asked the subject to rate the pain by Verbal pain scale (VPS),duration of anesthesia 30, 60 and 90 minutes after removal Using 22G-needle connected to the digital depth gauge inserted into skin and asked the subject to rate the pain by Verbal pain scale (VPS)