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:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT03699267
Eligibility Criteria:
Inclusion Criteria:
* Patients of age superior 18 years-old;
* Patients scheduled to unilateral breast reconstruction surgery with TRAM flap or partial/total or totalization mastectomy followed by TRAM reconstruction whose anesthetic plan was GBA or GBA + TAP.
Exclusion Criteria:
* Refusal to participate in study;
* Inability to sign written informed consent;
* Body mass index superior (BMI) 40 kg/m2;
* Opioid tolerance (defined as previous consume, minimum period of 2 months, ≥ 50 mg morphine equivalents, per os);
* Substance abuse (addiction syndrome)
* Renal chronic disease with creatinine clearance \< 30 mL/min/1.73m2); hepatic disease (Child-Pugh score of 1, 2 or 3);
* Patients subjected to other surgeries within the same operative time
* Patients that TAP block was not performed before surgical incision and the dose and volume of ropivacaine wasn't 20 mL, ropivacaine 0.375%
* Patients whose systemic analgesic protocol wasn't that adopted by Anesthesiology Department for this kind of surgery
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03699267
Study Brief:
Protocol Section:
NCT03699267