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Lidocaine Patches for Attenuating the Pain of Venipuncture Intravenous Cannulation

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status and phase

Unknown
Phase 3
Phase 2

Conditions

We Focus on the Pain of Venipuncture and Intravenous Cannulation

Treatments

Drug: Lidocaine Patches

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02061475
LCLDKY-13115

Details and patient eligibility

About

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.

Enrollment

240 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

240 participants in 2 patient groups, including a placebo group

Lidocaine Patches
Active Comparator group
Treatment:
Drug: Lidocaine Patches
Placebo Patches
Placebo Comparator group

Trial contacts and locations

8

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Central trial contact

Diansan Su, Dr.

Data sourced from clinicaltrials.gov

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