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Status unknownNCT02061475Updated Aug 29, 2014

Lidocaine Patches for Attenuating the Pain of Venipuncture Intravenous Cannulation

A Phase 2/3 interventional study of Lidocaine Patches in We Focus on the Pain of Venipuncture and Intravenous Cannulation, sponsored by RenJi Hospital. Status unknown at 8 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-08-29.

Sponsored by RenJi Hospital · Phase 2/3, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jun 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • We Focus on the Pain of Venipuncture and Intravenous Cannulation

Keywords

  • Lidocaine patches
  • Pain
  • Intravenous cannulation
03

In context

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
240 participants (estimated)

Study arms

  • Active comparator
    Lidocaine Patches

    Drug: Lidocaine Patches

  • Placebo comparator
    Placebo Patches

Interventions

  • DrugLidocaine Patches
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Two minters after intravenous cannulation

  2. Skin response after intravenous cannulation

    Local skin response to the lidocaine patches will be evaluated thirty minters after intravenous cannulation

    Time frame: Thirty minters after intravenous cannulation

07

Study locations

8 of 8 sites recruiting
  • Peking University First Hospital
    Beijing, Beijing 100034, China
    • Xinmin Wu, Dr. · Contact · 0086-10-83572784
    • Xinmin Wu, Dr. · Principal investigator
    Recruiting
  • Guanzhou First people's Hospital
    Guangzhou, Guangdong 510180, China
    • Lixin Xu, Dr. · Contact · 0086-20-81048305
    • Lixin Xu, Dr. · Principal investigator
    Recruiting
  • Xiangya Hospital Central South University
    Changhai, Hunan 410008, China
    • Qulian Guo, Dr. · Contact · 0086-731-84327411
    • Qulian Guo, Dr. · Principal investigator
    Recruiting
  • The First Affiliate Hospital of Soochow University
    Suzhou, Jiangsu 215006, China
    • Jianping Yang, Dr. · Contact · 0086-512-67780149
    • Jianping Yang, Dr. · Principal investigator
    Recruiting
  • Shengjing Hospital of China Medical University
    Shenyang, Liaoning 110004, China
    • Xiuying Wu, Dr. · Contact · 0086-24-83955027
    • Xiuying Wu, Dr. · Principal investigator
    Recruiting
  • Zhongshan Hospital Affiliated to Shanghai Fudan University
    Shanghai, Shanghai 200032, China
    • Zhanggang Xue, Dr. · Contact · 0086-21-64041990
    • Zhanggang Xue, Dr. · Principal investigator
    Recruiting
  • Renji Hospital, School of Medicine, Shanghai Jiaotong University
    Shanghai, Shanghai 200127, China
    Recruiting
  • Shanghai First People's Hospital
    Shanghai, Shanghai 201620, China
    • Shitong Li, Dr. · Contact · 0086-21-63240090
    • Shitong Li, Dr. · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02061475
Lead sponsor
RenJi Hospital
Collaborators
Nitto Denko Corporation, Giant Med-Pharma Services Inc.
Responsible party
Sponsor
First posted
Feb 12, 2014
Start date
Apr 2014
Primary completion
Mar 2015 (estimated)
Completion
Mar 2015 (estimated)
Last update
Aug 29, 2014

Study contacts

Diansan Su, Dr.
Contact
diansansu@yahoo.com
0086-21-68383702
Diansan Su, Dr.
principal investigator · Renji Hospital, School of Medicine, Shanghai Jiaotong University
Xiangrui Wang, Dr.
study chair · Renji Hospital, School of Medicine, Shanghai Jiaotong University
Yanhua Zhao, Dr.
principal investigator · Renji Hospital, School of Medicine, Shanghai Jiaotong University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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