Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 8:01 PM
Ignite Modification Date:
2025-12-24 @ 8:01 PM
NCT ID:
NCT02035904
Eligibility Criteria:
Inclusion Criteria:
* F; age 18 to 70
* American Society of Anesthesiologists (ASA) I e II;
* breast cancer ( DIN 2 e 3, o LIN 2 e 3 sec. Tavassoli) scheduled for nipple-sparing mastectomy, simple mastectomy, skin-sparing mastectomy, skin-reducing mastectomy c, lymphnode biopsy and axillary dissection;
* immediate sub-pectoral prosthetic reconstruction;
* signed informed consent.
Exclusion Criteria:
* preexisting pectoral, axillar, thoracic homolateral pain
* habitual opioid consumption;
* drug-alcoholics addiction ;
* ICU postoperative recovery;
* kidney failure (creatinin \> 2 g/dl, creatinin \<clearance 30 ml/h) and/or hepatic failure (cholinesterase \< 2000 UI);
* cardiac arrhythmias o;
* Epilepsy;
* Psychiatric, cognitive disorders, mental retardation;
* Coagulopathies (INR \> 2, activated partial thromboplastin time - aPTT\>44 sec);
* platelet count less than 100.000/mm3;
* BMI \> 30;
* Allergies to study drugs.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02035904
Study Brief:
Protocol Section:
NCT02035904