ew regional anesthesia technique can be better than local anesthetic infiltration at surgical site in patients undergoing breast cancer surgical removal
Not Applicable
Recruiting
- Conditions
- Breast Cancerpostoperative painchronic painR52.2R52.0
- Registration Number
- RBR-48b9cz
- Lead Sponsor
- AC Camargo Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
Patients older than 18 years; female; to be submitted to mastectomy with lymphadenectomy and unilateral breastl reconstruction (prosthesis or expander); described surgeries taking place at AC Camargo Cancer Center; no history of allergy to any medication used in the study; absence of contraindication to the
regional block (coagulopathy and / or local infection); acceptance to participate in the study.
Exclusion Criteria
Patients who require a new surgery within 6 months after mastectomy; patients to whom we cannot contact in periods of 3 and 6 months post surgery; patients who require radiotherapy treatment; patients in which occur block failure.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ower morphine consumption among patients exposed to the block when compared to those not exposed, through total morphine consumed in the hours after surgery.<br>• Average morphine consumption between exposed cases:<br>1%.<br>• Average morphine consumption among unexposed cases: 1.5%.<br>• Significance level: 5%.<br>• Test power: 95%.<br>• Sample size calculated for each group:<br>46<br>In order to evaluate a possible difference in the pain intensity between the anesthetic techniques used, the Mann-Whitney U test will be applied. Analysis will be performed using SPSS software version 23 and software R version<br>3.4
- Secondary Outcome Measures
Name Time Method Secondary outcomes are not expected.