NCT06600815 Analgesic Efficacy of Preemptive Stepwise Infiltration Anesthesia for Perioperative Analgesia After TKA
| NCT ID | NCT06600815 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital of Fujian Medical University |
| Condition | Total Knee Arthroplasty |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2024-09-30 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2024-09-30 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: Patients must meet all of the following criteria to be eligible for inclusion: 1. 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 hospital. 2. Preoperative American Society of Anaesthesiologists (ASA) score ranging from 1 to 3. Surgeons deemed the patient eligible for TKA based on the evaluation criteria. 3. Participants aged 18 years or older, both male and female. 4. Ability to provide informed consent and sign a written informed consent form. 5. The ability to comprehend the research requirements and willingness to cooperate with the study instructions. Exclusion Criteria: Patients will be excluded if they meet any of the following criteria: 1. Previous knee surgery on the operative knee or a history of infection in the operative knee. 2. Patients diagnosed with conditions other than osteoarthritis (including rheumatoid arthritis, traumatic arthritis, septic arthritis and haemophilic arthritis). 3. Severe osteoarthritis (including flexion contracture \>30° or varus/valgus deformity \>30° and the use of unconventional arthroplasty components due to complex joint pathology \[e.g., restrictive prostheses\]). 4. Allergy to the investigational drug. 5. The presence of neuromuscular dysfunction on the operative side. 6. 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). 7. 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 heart failure, or any acute coronary events within the past 6 months; severe hepatic or renal dysfunction; and pregnancy or lactation. 8. Concurrent participation in clinical trials other than this trial.
Contact & Investigator
Wenming Zhang, MD
STUDY DIRECTOR
First Affiliated Hospital of Fujian Medical University
Frequently Asked Questions
Who can join the NCT06600815 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Total Knee Arthroplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06600815 currently recruiting?
Yes, NCT06600815 is actively recruiting participants. Contact the research team at 9738006@qq.com for enrollment information.
Where is the NCT06600815 trial being conducted?
This trial is being conducted at Fuzhou, China.
Who is sponsoring the NCT06600815 clinical trial?
NCT06600815 is sponsored by First Affiliated Hospital of Fujian Medical University. The principal investigator is Wenming Zhang, MD at First Affiliated Hospital of Fujian Medical University. The trial plans to enroll 110 participants.