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 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT05935059
Eligibility Criteria:
Inclusion Criteria:
1. Breast cancer female patients.
2. ASA class II and III.
3. Age ≥ 18 and ≤ 60 Years.
4. Body mass index (BMI): \> 20 kg/m2 and \< 35 kg/m2.
5. Type of surgery; elective breast cancer surgery (either modified radical mastectomy or conservative breast surgery) combined with axillary dissection.
Exclusion Criteria:
1. Patient refusal.
2. Age \<18 years or \>65 years.
3. BMI \<20 kg/m2 and \>35 kg/m2.
4. Known sensitivity or contraindication to drugs used in the study (Pregabalin , Tianeptine , NSAIDs, or morphine ).
5. History of psychiatric disorders or history of major depression.
6. History of chronic pain that necessitates morphine at a daily dose of 30 mg or more (or equivalent opioids).
7. history of gapabentenoids or antidepressant intake in the preceding three months.
8. Major medical conditions.
9. Pregnancy or lactation.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05935059
Study Brief:
Protocol Section:
NCT05935059