Clinical trial NCT02061475: Lidocaine Patches for Attenuating the Pain of Venipuncture Intravenous Cannulation
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: We Focus on the Pain of Venipuncture and Intravenous Cannulation
Keywords: Lidocaine patches
Pain
Intravenous cannulation
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Nitto Denko Corporation
name: Giant Med-Pharma Services Inc.
First posted: 2014-02-12
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: The efficiency of lidocaine patches for attenuating the pain of venipuncture intravenous cannulation before surgery
timeFrame: Two minters after intravenous cannulation
measure: Skin response after intravenous cannulation
timeFrame: Thirty minters after intravenous cannulation
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guanzhou First people's Hospital
state: Guangdong
city: Changhai
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Suzhou
country: China
facility: The First Affiliate Hospital of Soochow University
state: Jiangsu
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Shanghai
country: China
facility: Zhongshan Hospital Affiliated to Shanghai Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai First People's Hospital
state: Shanghai
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiaotong University
name: Diansan Su, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Renji Hospital, School of Medicine, Shanghai Jiaotong University
name: Xiangrui Wang, Dr.
role: STUDY_CHAIR
affiliation: Renji Hospital, School of Medicine, Shanghai Jiaotong University
name: Yanhua Zhao, Dr.
role: PRINCIPAL_INVESTIGATOR
References: