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 @ 4:56 AM
Ignite Modification Date:
2025-12-25 @ 4:56 AM
NCT ID:
NCT06557018
Eligibility Criteria:
Inclusion Criteria:
1. Male or female, age ≥ 18 years.
2. American Society of Anesthesiologists (ASA) classification of grade I-II, with a certain level of literacy, good comprehension of Chinese language and text, no obstacles in doctor-patient communication, good understanding of visual analog scoring of pain (VAS scoring), and the ability to actively cooperate with the relevant examinations
3. Proposed initial unilateral total knee arthroplasty (TKA) under general anesthesia without any previous history of knee surgery.
4. The patients will participate in the study voluntarily, sign an informed consent form, and cooperate with all the assessments.
Exclusion Criteria:
1. Patients with other pain management options prior to surgery
2. Patients with neuromuscular pathology in the operated limb with other comorbidities that may affect postoperative recovery
3. Patients with allergy, hypersensitivity, intolerance, or contraindication to any of the drugs on study
4. Patients with a history of coronary artery, vascular stent placement, deep vein thrombosis, pulmonary embolism, myocardial infarction, or ischemic stroke treated within the past 6 months
5. The existence of serious liver and kidney dysfunction, coagulation disorders, cardiac arrhythmia, infection and other contraindications to surgery；
6. patients with any neurological or psychiatric disorders that may affect postoperative pain or interfere with study evaluation；
7. Patients with a history of misuse, abuse, or dependence on opioid analgesics, other prescription drugs, illicit drugs, or alcohol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06557018
Study Brief:
Protocol Section:
NCT06557018