Actively Recruiting
Analgesic Efficacy of Preemptive Stepwise Infiltration Anesthesia for Perioperative Analgesia After Total Knee Arthroplasty: a Prospective Double-blind Randomized Controlled Clinical Trial
Led by First Affiliated Hospital of Fujian Medical University · Updated on 2024-10-17
110
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating different pain management methods for patients undergoing total knee arthroplasty (TKA) due to primary unilateral knee osteoarthritis. This prospective, double-blind randomized controlled trial aims to compare preemptive stepwise infiltration anaesthesia (PSIA) with postoperative local infiltration analgesia (PLIA) to find the optimal way to manage pain and inflammation around the time of surgery. The study plans to enroll 110 patients who meet specific health and diagnostic criteria at a single center.
CONDITIONS
Brief 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 with Kellgren-Lawrence score of 2 or higher
- Scheduled for initial unilateral total knee arthroplasty at the study hospital
- Preoperative American Society of Anaesthesiologists (ASA) score between 1 and 3
- Age 18 years or older, any gender
- Ability to provide and sign informed consent
- Ability to understand and comply with study instructions and requirements
You will not qualify if you...
- Previous surgery or infection in the operative knee
- Diagnosis of other joint conditions besides osteoarthritis, such as rheumatoid arthritis or septic arthritis
- Severe osteoarthritis with flexion contracture over 30 degrees or varus/valgus deformity over 30 degrees requiring special prostheses
- Allergy to the anaesthetic drugs used in the study
- Presence of neuromuscular dysfunction on the operative side
- Dependence on opioids or local anaesthetics exceeding 100 mg morphine equivalents per week for more than 3 months
- Poor overall health including high blood sugar, uncontrolled blood pressure, recent heart attack or stroke, severe liver or kidney problems, pregnancy or breastfeeding
- Participation in other clinical trials besides this one
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment and informed consent
Duration - Day of surgery
Participants undergo total knee arthroplasty (TKA) and receive either preemptive stepwise infiltration anesthesia (PSIA) or postoperative local infiltration analgesia (PLIA) during surgery for pain management.
1 surgical visit (in-person)
Duration - From 6 hours to 6 months post-surgery
Participants are monitored for postoperative pain, morphine consumption, joint function, and inflammatory responses through clinical evaluations after surgery.
Visits at 6, 12, 24, 48, 72 hours and at 3 weeks, 6 weeks, and 6 months postoperatively
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
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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