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Lidocaine Patches for Attenuating the Pain of Venipuncture Intravenous Cannulation

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02061475
Enrollment
240
Registered
2014-02-12
Start date
2014-04-30
Completion date
2015-03-31
Last updated
2014-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

We Focus on the Pain of Venipuncture and Intravenous Cannulation

Keywords

Lidocaine patches, Pain, Intravenous cannulation

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.

Interventions

Sponsors

Nitto Denko Corporation
CollaboratorINDUSTRY
Giant Med-Pharma Services Inc.
CollaboratorINDUSTRY
RenJi Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
The efficiency of lidocaine patches for attenuating the pain of venipuncture intravenous cannulation before surgeryTwo minters after intravenous cannulationVAS score will be evaluated two minters after intravenous cannulation in both group with lidocaine patches or not.
Skin response after intravenous cannulationThirty minters after intravenous cannulationLocal skin response to the lidocaine patches will be evaluated thirty minters after intravenous cannulation

Countries

China

Contacts

Primary ContactDiansan Su, Dr.
diansansu@yahoo.com0086-21-68383702

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026