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Tests treatment safety and results for Total Knee Arthroplasty
Official title Analgesic Efficacy of Preemptive Stepwise Infiltration Anesthesia for Perioperative Analgesia After TKA
ClinicalTrials.gov ID: NCT06600815
What this study is testing
- What it's testing
- This is a single-center prospective cohort study in which patients were evaluated by inclusion and exclusion criteria before total knee arthroplasty (TKA). Eligible patients will be included in this study after signing the informed consent form.
- Time commitment: about 1 year
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Patients must meet all of the following criteria to be eligible for inclusion:
- Clinical diagnosis of primary unilateral knee osteoarthritis (KOA), confirmed by imaging as KOA (Kellgren-Lawrence score ≥2). The patient was...
- Preoperative American Society of Anaesthesiologists (ASA) score ranging from 1 to 3. Surgeons deemed the patient eligible for TKA based on the...
- Participants aged 18 years or older, both male and female.
- Ability to provide informed consent and sign a written informed consent form.
You likely can't join if
- Patients will be excluded if they meet any of the following criteria:
- Previous knee surgery on the operative knee or a history of infection in the operative knee.
- Patients diagnosed with conditions other than osteoarthritis (including rheumatoid arthritis, traumatic arthritis, septic arthritis and haemophilic...
- Severe osteoarthritis (including flexion contracture \>30° or varus/valgus deformity \>30° and the use of unconventional arthroplasty components due...
- Allergy to the investigational drug.
- The presence of neuromuscular dysfunction on the operative side.
See the full eligibility criteria
- Patients must meet all of the following criteria to be eligible for inclusion:
- Clinical diagnosis of primary unilateral knee osteoarthritis (KOA), confirmed by imaging as KOA (Kellgren-Lawrence score ≥2). The patient was scheduled for initial unilateral total knee arthroplasty (TKA) at our...
- Preoperative American Society of Anaesthesiologists (ASA) score ranging from 1 to 3. Surgeons deemed the patient eligible for TKA based on the evaluation criteria.
- Participants aged 18 years or older, both male and female.
- Ability to provide informed consent and sign a written informed consent form.
- The ability to comprehend the research requirements and willingness to cooperate with the study instructions.
- Patients will be excluded if they meet any of the following criteria:
- Previous knee surgery on the operative knee or a history of infection in the operative knee.
- Patients diagnosed with conditions other than osteoarthritis (including rheumatoid arthritis, traumatic arthritis, septic arthritis and haemophilic arthritis).
- Severe osteoarthritis (including flexion contracture \>30° or varus/valgus deformity \>30° and the use of unconventional arthroplasty components due to complex joint pathology [e.g., restrictive prostheses]).
- Allergy to the investigational drug.
- The presence of neuromuscular dysfunction on the operative side.
- Dependence on anaesthesia drugs (defined as the use of opioid or local anaesthetic drugs exceeding 100 mg of morphine equivalents per week to control preoperative pain for more than 3 months).
- Poor overall health conditions, including but not limited to a glycated haemoglobin level exceeding 12%; blood pressure exceeding 170/110 mmHg; myocardial infarction, stroke, transient ischaemic attack, acute congestive...
- Concurrent participation in clinical trials other than this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.