A Double Blind Randomized Controlled Study of the Effiacy and Safety of Topical Sterile 5% Lidocaine Patch in the Treatment of Postoperative Pain Due to Plastic Surgery of the Breast

• Conditions: Postoperative Pain Due to the Plastic Surgery of the Breast

• Registration Number: EUCTR2006-001487-23-LV
• Lead Sponsor: Teikoku Pharma USA, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Healthy females 18-60 years of age with a planned surgery for plastic surgery of the breast;
Agrees to sign and date an Ethics Committee approved informed consent;
Must be undergoing plastic surgery of both breasts for reduction or enlargement;
In good health on the basis of medical history, physical examination, ECG and routine laboratory tests per the judgement of the clinicial;
Is reliable and mentally competent to complete study diaries;
Agrees to use the study medication as required by the protocol;
I able to read, speak and understand Latvian, Russian or English;
Is using an acceptable birth control method;
Is available for the study visits and telepfone checks during the duration of treatment (6-8 days following surgery)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Females with any malignancy or suspected malignancy, or has received treatment for a malignancy within the past 5 years,
Has used analgesics, steroids, or sedatives in the treatment of the chronic disease within the past 3 months,
Has a history of hypersensivity to lidocaine, aspirin or other analgesics,
has chronic renal or hepatic disease having serum creatinine levels 1.25 times above the upper limit of normal and AST/ALT levels 1.5 times above the upper limit of normal,
Smokes more than 15 cigarettes per day,
Is a known alchocol or drug abuser,
Needs more extensive surgery such as mastectomy or reconstruction of the breast,
Is having breast augmentation via transaxial or transumbilical incisions,
Has had previous surgery in the same area,
Has participated in any other clinivcal trial within the past 60 days,
Clinical evidence of any sinificant chronic illness;
Any condition that the Investigator believes would interfere with evaluation of the subject or may put the subject at undue risk.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this double-blind, vehicle-controlled trial is to test the analgesic efficacy and safety of the sterile 5 % lidocaine patch for treatment of postoperative pain, specifically due to plastic surgery of the breast.;Secondary Objective: ;Primary end point(s): Time-to-Pain Resolution will be defined as the time of the initial patch application to when the subject records the fourth consecuitive Categorical Pain Score of 2 or less on the Categorical Pain Scale.