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 @ 3:25 PM
Ignite Modification Date:
2025-12-24 @ 3:25 PM
NCT ID:
NCT07231692
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 18-80 years scheduled for elective unilateral total knee arthroplasty (TKA) under spinal anesthesia
* ASA physical status I-III
* Eligible for and capable of using patient-controlled analgesia (PCA)
* Provided written informed consent
Exclusion Criteria:
* Chronic opioid use for more than four weeks before surgery
* Presence of chronic pain conditions (e.g., migraine, fibromyalgia)
* History of alcohol or drug abuse
* Known allergy or hypersensitivity to local anesthetics or opioids
* Severe organ dysfunction (e.g., significant hepatic or renal disease)
* Revision or bilateral knee arthroplasty
* Contraindications to regional anesthesia
* Preexisting neuropathy or prior femoral vascular surgery on the operated side.
* Infection near the injection site (e.g., osteomyelitis, septic joint).
* Contraindication to spinal anesthesia (e.g., refusal, coagulopathy, use of anticoagulants or antiplatelet agents) or inability to understand NRS.
* Severe psychiatric or cognitive disorders (e.g., psychosis, dementia) that prevent cooperation or pain assessment
* Pregnant or breastfeeding women
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07231692
Study Brief:
Protocol Section:
NCT07231692