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Lidocaine Patches for Attenuating the Pain of Venipuncture Intravenous Cannulation

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ClinicalTrials.gov Identifier: NCT02061475
Recruitment Status : Unknown
Verified June 2014 by RenJi Hospital.
Recruitment status was:  Recruiting
First Posted : February 12, 2014
Last Update Posted : August 29, 2014
Sponsor:
Collaborators:
Nitto Denko Corporation
Giant Med-Pharma Services Inc.
Information provided by (Responsible Party):
RenJi Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
We Focus on the Pain of Venipuncture and Intravenous Cannulation Drug: Lidocaine Patches Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : April 2014
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lidocaine Patches Drug: Lidocaine Patches
Placebo Comparator: Placebo Patches



Primary Outcome Measures :
  1. 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.

  2. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061475


Contacts
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Contact: Diansan Su, Dr. 0086-21-68383702 diansansu@yahoo.com

Locations
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China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Xinmin Wu, Dr.    0086-10-83572784      
Principal Investigator: Xinmin Wu, Dr.         
China, Guangdong
Guanzhou First people's Hospital Recruiting
Guangzhou, Guangdong, China, 510180
Contact: Lixin Xu, Dr.    0086-20-81048305      
Principal Investigator: Lixin Xu, Dr.         
China, Hunan
Xiangya Hospital Central South University Recruiting
Changhai, Hunan, China, 410008
Contact: Qulian Guo, Dr.    0086-731-84327411      
Principal Investigator: Qulian Guo, Dr.         
China, Jiangsu
The First Affiliate Hospital of Soochow University Recruiting
Suzhou, Jiangsu, China, 215006
Contact: Jianping Yang, Dr.    0086-512-67780149      
Principal Investigator: Jianping Yang, Dr.         
China, Liaoning
Shengjing Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110004
Contact: Xiuying Wu, Dr.    0086-24-83955027      
Principal Investigator: Xiuying Wu, Dr.         
China, Shanghai
Zhongshan Hospital Affiliated to Shanghai Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Zhanggang Xue, Dr.    0086-21-64041990 ext 3702      
Principal Investigator: Zhanggang Xue, Dr.         
Renji Hospital, School of Medicine, Shanghai Jiaotong University Recruiting
Shanghai, Shanghai, China, 200127
Contact: Diansan Su, Dr.       diansansu@yahoo.com   
Principal Investigator: Yanhua Zhao, Dr.         
Shanghai First People's Hospital Recruiting
Shanghai, Shanghai, China, 201620
Contact: Shitong Li, Dr.    0086-21-63240090 ext 3023      
Principal Investigator: Shitong Li, Dr.         
Sponsors and Collaborators
RenJi Hospital
Nitto Denko Corporation
Giant Med-Pharma Services Inc.
Investigators
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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

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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT02061475     History of Changes
Other Study ID Numbers: LCLDKY-13115
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: August 29, 2014
Last Verified: June 2014

Keywords provided by RenJi Hospital:
Lidocaine patches
Pain
Intravenous cannulation

Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action