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 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT02729805
Eligibility Criteria:
Inclusion Criteria:
* the American Society of Anesthesiologists adopted physical status classification system (ASA) I-III
* Age 18-80 years old
* Scheduled for 1) modified radical mastectomy (including axillary lymph node dissection) and 2) mastectomy with sentinel lymph node (without axillary dissection). These are the common surgical treatments for breast cancer.
Exclusion Criteria:
* Radical mastectomy, wide local excision or lumpectomy
* Known allergy to opioids, local anaesthetic drugs, non-steroidal anti-inflammatory drugs (NSAIDS) including COX-2 inhibitors
* History of chronic pain
* Alcohol or drug abuse
* Impaired renal function, defined as preoperative serum creatinine level over 120 micromol/L
* Pre-existing neurological or muscular disorders
* Psychiatric illness
* Impaired or retarded mental state
* Not self ambulatory before operation
* Difficulties in using patient controlled analgesia (PCA)
* Pregnancy
* Local infection
* Patient refusal
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02729805
Study Brief:
Protocol Section:
NCT02729805