EUCTR2006-001487-23-LV
Active, not recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postoperative Pain Due to the Plastic Surgery of the Breast
- Sponsor
- Teikoku Pharma USA, Inc.
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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,
Outcomes
Primary Outcomes
Not specified
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