Lidocaine Patches for Attenuating the Pain of Venipuncture Intravenous Cannulation

NCT ID: NCT02061475

Last Updated: 2014-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-03-31

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.

Detailed Description

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Conditions

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We Focus on the Pain of Venipuncture and Intravenous Cannulation

Keywords

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Lidocaine patches Pain Intravenous cannulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lidocaine Patches

Group Type ACTIVE_COMPARATOR

Lidocaine Patches

Intervention Type DRUG

Placebo Patches

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Lidocaine Patches

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nitto Denko Corporation

INDUSTRY

Sponsor Role collaborator

Giant Med-Pharma Services Inc.

INDUSTRY

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Diansan Su, Dr.

Role: PRINCIPAL_INVESTIGATOR

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Xiangrui Wang, Dr.

Role: STUDY_CHAIR

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Yanhua Zhao, Dr.

Role: PRINCIPAL_INVESTIGATOR

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Locations

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Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Guanzhou First people's Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Xiangya Hospital Central South University

Changhai, Hunan, China

Site Status RECRUITING

The First Affiliate Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Site Status RECRUITING

Zhongshan Hospital Affiliated to Shanghai Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Diansan Su, Dr.

Role: CONTACT

Phone: 0086-21-68383702

Email: [email protected]

Facility Contacts

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Xinmin Wu, Dr.

Role: primary

Lixin Xu, Dr.

Role: primary

Qulian Guo, Dr.

Role: primary

Jianping Yang, Dr.

Role: primary

Xiuying Wu, Dr.

Role: primary

Zhanggang Xue, Dr.

Role: primary

Diansan Su, Dr.

Role: primary

Shitong Li, Dr.

Role: primary

Other Identifiers

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LCLDKY-13115

Identifier Type: -

Identifier Source: org_study_id