Lidocaine Patches for Attenuating the Pain of Venipuncture Intravenous Cannulation

Study Overview
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Brief Summary
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Venipuncture and intravenous cannulation are the most common painful procedures, especially for the penitents who must receive large diameter venous catheter before surgery. In present study we would evaluate the safety and validity of lidocaine patches releasing such pain.

Official Title
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The Efficacy and Safety of Lidocaine Patches for Attenuating the Pain of Venipuncture Intravenous Cannulation Before Surgery: a Multicenter, Randomized, Double -Blind, Placebo-controled and Parallel-group Designed Clinical Trail

Conditions
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We Focus on the Pain of Venipuncture and Intravenous Cannulation

Intervention / Treatment
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* Drug: Lidocaine Patches


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who want to participate present study and sign the informed consent form Age from 18 to 65 years old Patients who need intravenous cannulation before surgery ASA class I-II and selected patients Exclusion Criteria: Allergic to lidocaine or any other amide local anesthetics or any other medicine Allergic skin(allergic to past agent or other topical used medicine) Skin injured or inflection exist in the local site to patch Sensation disturbed in any limb Severe liver and kidney original disease:blood Aspertate aminotransferase and Alanine transaminase increased 1.5 times more than normal concentration; blood creatinine is higher than the normal range. Hemoglobin <80g/L ECG is significantly abnormal pregnant or possible pregnant or breastfeeding woman Patient who has consciousness disturbance can not make credible dialog with investigator. Those who are using other medicine may affect the evaluation of present patch Those who have participated in other clinical trail in the past three months Those excluded by investigator believed other reasons.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine Patches<br> | Drug: Lidocaine Patches<br> <br> |
| Placebo Comparator: Placebo Patches<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficiency of lidocaine patches for attenuating the pain of venipuncture intravenous cannulation before surgery | VAS score will be evaluated two minters after intravenous cannulation in both group with lidocaine patches or not. | Two minters after intravenous cannulation | 
| Skin response after intravenous cannulation | Local skin response to the lidocaine patches will be evaluated thirty minters after intravenous cannulation | Thirty minters after intravenous cannulation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Intravenous cannulation, Lidocaine patches