Actively Recruiting
Analgesic Efficacy of Preemptive Stepwise Infiltration Anesthesia for Perioperative Analgesia After TKA
Led by First Affiliated Hospital of Fujian Medical University · Updated on 2024-10-17
110
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. Before TKA, the patients will be randomly assigned to either a preemptive stepwise infiltration anaesthesia (PSIA) group or a postoperative local infiltration analgesia (PLIA) group and administered different pain management protocols during surgery. Clinical evaluation will be conducted at baseline, before surgery, and at 6, 12, 24, 48, and 72 hours postoperatively, as well as during follow-up visits at 3 weeks, 6 weeks and 6 months postoperatively. All patients voluntarily participated in the study and signed informed consent. During the treatment period, all prospective patients underwent clinical evaluation at the end of total knee arthroplasty and 6, 12, 24, 48, 72, and 96 weeks later, aimed at comparing the postoperative pain and inflammatory response between PSIA and PLIA, to explore the optimal perioperative analgesic modality for TKA.
CONDITIONS
Official Title
Analgesic Efficacy of Preemptive Stepwise Infiltration Anesthesia for Perioperative Analgesia After TKA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of primary unilateral knee osteoarthritis confirmed by imaging (Kellgren-Lawrence score 62)
- Scheduled for initial unilateral total knee arthroplasty at the study hospital
- Preoperative American Society of Anaesthesiologists (ASA) score of 1 to 3
- Aged 18 years or older, any gender
- Ability to provide and sign written informed consent
- Willingness and ability to understand and cooperate with study requirements
You will not qualify if you...
- Previous knee surgery or infection in the operative knee
- Diagnosed with other arthritis types such as rheumatoid, traumatic, septic, or haemophilic arthritis
- Severe osteoarthritis with flexion contracture >30 or varus/valgus deformity >30 requiring unconventional prostheses
- Allergy to the study drugs
- Neuromuscular dysfunction on the operative side
- Dependence on anesthesia drugs exceeding 100 mg morphine equivalents per week for more than 3 months
- Poor health conditions including high glycated hemoglobin (>12%), high blood pressure (>170/110 mmHg), recent serious cardiac or stroke events, severe liver or kidney dysfunction, pregnancy or lactation
- Participation in other clinical trials concurrently
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Actively Recruiting
Research Team
X
Xinyu Fang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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