Pain management techniques for knee surgery

Analgesic Efficacy of Preemptive Stepwise Infiltration Anesthesia for Perioperative Analgesia After Total Knee Arthroplasty: a Prospective Double-blind Randomized Controlled Clinical Trial

This study tests two different ways to manage pain for people having knee surgery to see which one helps them feel better afterward.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: First Affiliated Hospital of Fujian Medical University (other)
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT06600815 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of two different pain management techniques for patients undergoing total knee arthroplasty (TKA). Participants will be randomly assigned to receive either preemptive stepwise infiltration anesthesia (PSIA) or postoperative local infiltration analgesia (PLIA) during their surgery. Clinical evaluations will be conducted at various time points before and after the surgery to assess pain levels, morphine consumption, and joint function. The study aims to recruit 110 patients over the course of one year at a single medical center.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a clinical diagnosis of primary unilateral knee osteoarthritis scheduled for TKA.

Not a fit: Patients with previous knee surgery on the operative knee or those with conditions other than osteoarthritis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing knee surgery, enhancing recovery and overall patient satisfaction.

How similar studies have performed: Other studies have shown promising results with similar pain management approaches, suggesting potential for success in this study.

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.

Where this trial is running

Fuzhou, Fujian

• The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (RECRUITING)

Study contacts

• Study coordinator: Xinyu Fang, MD

Conditions: Total Knee Arthroplasty, Pain Management, Total knee arthroplasty, Pain management, Anaesthesia in orthopaedics