Lidocaine Patches for Attenuating the Pain of Venipuncture Intravenous Cannulation

August 28, 2014 updated by: RenJi Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University first hospital
        • Contact:
          • Xinmin Wu, Dr.
          • Phone Number: 0086-10-83572784
        • Principal Investigator:
          • Xinmin Wu, Dr.
    • Guangdong
      • Guangzhou, Guangdong, China, 510180
        • Recruiting
        • Guanzhou First people's Hospital
        • Contact:
          • Lixin Xu, Dr.
          • Phone Number: 0086-20-81048305
        • Principal Investigator:
          • Lixin Xu, Dr.
    • Hunan
      • Changhai, Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital Central South University
        • Contact:
          • Qulian Guo, Dr.
          • Phone Number: 0086-731-84327411
        • Principal Investigator:
          • Qulian Guo, Dr.
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • The First Affiliate Hospital of Soochow University
        • Contact:
          • Jianping Yang, Dr.
          • Phone Number: 0086-512-67780149
        • Principal Investigator:
          • Jianping Yang, Dr.
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Recruiting
        • Shengjing Hospital of China Medical University
        • Contact:
          • Xiuying Wu, Dr.
          • Phone Number: 0086-24-83955027
        • Principal Investigator:
          • Xiuying Wu, Dr.
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Renji Hospital, School of Medicine, Shanghai Jiaotong University
        • Contact:
        • Principal Investigator:
          • Yanhua Zhao, Dr.
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital Affiliated to Shanghai Fudan University
        • Contact:
          • Zhanggang Xue, Dr.
          • Phone Number: 3702 0086-21-64041990
        • Principal Investigator:
          • Zhanggang Xue, Dr.
      • Shanghai, Shanghai, China, 201620
        • Recruiting
        • Shanghai First People's Hospital
        • Contact:
          • Shitong Li, Dr.
          • Phone Number: 3023 0086-21-63240090
        • Principal Investigator:
          • Shitong Li, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Lidocaine Patches
Drug: Lidocaine Patches
PLACEBO_COMPARATOR: Placebo Patches

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The efficiency of lidocaine patches for attenuating the pain of venipuncture intravenous cannulation before surgery
Time Frame: Two minters after intravenous cannulation
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
Time Frame: Thirty minters after intravenous cannulation
Local skin response to the lidocaine patches will be evaluated thirty minters after intravenous cannulation
Thirty minters after intravenous cannulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Collaborators

Nitto Denko Corporation
Giant Med-Pharma Services Inc.

Investigators

  • Principal Investigator: Diansan Su, Dr., Renji Hospital, School of Medicine, Shanghai Jiaotong University
  • Study Chair: Xiangrui Wang, Dr., Renji Hospital, School of Medicine, Shanghai Jiaotong University
  • Principal Investigator: Yanhua Zhao, Dr., Renji Hospital, School of Medicine, Shanghai Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ANTICIPATED)

March 1, 2015

Study Completion (ANTICIPATED)

March 1, 2015

Study Registration Dates

First Submitted

February 11, 2014

First Submitted That Met QC Criteria

February 11, 2014

First Posted (ESTIMATE)

February 12, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

August 29, 2014

Last Update Submitted That Met QC Criteria

August 28, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCLDKY-13115

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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