NCT02061475

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

August 29, 2014

Status Verified

June 1, 2014

Enrollment Period

11 months

First QC Date

February 11, 2014

Last Update Submit

August 28, 2014

Conditions

We Focus on the Pain of Venipuncture and Intravenous Cannulation

Keywords

Lidocaine patchesPainIntravenous cannulation

Outcome Measures

Primary Outcomes (2)

  • 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.

    Two minters after intravenous cannulation

  • Skin response after intravenous cannulation

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

    Thirty minters after intravenous cannulation

Study Arms (2)

Lidocaine Patches

ACTIVE COMPARATOR
Drug: Lidocaine Patches

Placebo Patches

PLACEBO COMPARATOR

Interventions

Lidocaine PatchesDRUG
Lidocaine Patches

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Guanzhou First people's Hospital

Guangzhou, Guangdong, 510180, China

RECRUITING

Xiangya Hospital Central South University

Changhai, Hunan, 410008, China

RECRUITING

The First Affiliate Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

Zhongshan Hospital Affiliated to Shanghai Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, 201620, China

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Diansan Su, Dr.

    Renji Hospital, School of Medicine, Shanghai Jiaotong University

    PRINCIPAL INVESTIGATOR

  • Xiangrui Wang, Dr.

    Renji Hospital, School of Medicine, Shanghai Jiaotong University

    STUDY CHAIR

  • Yanhua Zhao, Dr.

    Renji Hospital, School of Medicine, Shanghai Jiaotong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diansan Su, Dr.

CONTACT

0086-21-68383702diansansu@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2014

First Posted

February 12, 2014

Study Start

April 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

August 29, 2014

Record last verified: 2014-06

Locations

CN(8)