Analgesic Efficacy of Preemptive Stepwise Infiltration Anesthesia for Perioperative Analgesia After TKA

Официальное название

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

Обзор

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.

Подробное описание

This is a single-center prospective cohort study in which patients were evaluated by inclusion and exclusion criteria before total knee arthroplasty (TKA). This study aims to recruit 110 patients across a single centre over 1 year. 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. The primary outcomes are the amount of morphine consumed within 0-24 hours postsurgery and the visual analogue scale (VAS) score postsurgery. Secondary outcomes include the time to first rescue analgesia, total morphine consumption during hospitalization, postoperative joint function (measured by the Hospital for Special Surgery \[HSS\] score and knee joint range of motion \[ROM\]), intraoperative bleeding and serological indicators. 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 6h, 12h, 24h, 48h, 72h, 3 weeks, 6 weeks and 6 months later, aimed at comparing the postoperative pain and inflammatory response between PSIA and PLIA, to explore the optimal perioperative analgesic modality for TKA. Statistical analyses utilizing regression models and survival analysis will be conducted to assess the relationships between the pain management method and postoperative pain and efficacy.

Вмешательства

• Процедура preemptive stepwise infiltration anaesthesia(PSIA)
  For PSIA patients, the anaesthetic is administered in stages. Initially, CA is injected at the incision site before the medial parapatellar incision. Following skin incision, more CA is injected into the subcutaneous tissue. After exposing the fascial layer and joint capsule, CA is used around the patellar tendon, and then CB is injected into the joint capsule and surrounding muscles. Additional CB is applied to the synovium and soft tissues after the joint cavity is opened, and more is used in
• Процедура postoperative local infiltration analgesia(PLIA)
  Before standardized TKA and implantation of the prosthesis, 30-40 mL of CB will be used to infiltrate the synovium and whole joint capsule. Subsequently, the joint cavity, subcutaneous tissue, and skin will be closed layer by layer using routine procedures. After the skin is closed, 30-40 mL of CA will be injected into the skin and subcutaneous tissue.

Первичные конечные точки

• Postoperative morphine consumption within the first 24 hours [Срок оценки: the first 24 hours after TKA]
• . Postoperative visual analogue scale (VAS) scores at 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, 3 weeks, 6 weeks and 6 months [Срок оценки: 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, 3 weeks, 6 weeks and 6 months after TKA]

Вторичные конечные точки (12)

• Postoperative time to first rescue analgesia [Срок оценки: up to 3 days]
• Total morphine consumption during hospitalization [Срок оценки: through study completion, an average of 6 months]
• The Hospital for Special Surgery Knee Score (HSS) [Срок оценки: 3 weeks, 6 weeks and 6 months postoperatively]
• Range of motion (ROM) [Срок оценки: 3 weeks, 6 weeks and 6 months postoperatively]
• Direct intraoperative bleeding [Срок оценки: 24 hours postoperatively]
• Indirect intraoperative bleeding [Срок оценки: 24 hours postoperatively]
• Complete blood count [Срок оценки: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively]
• C-reactive protein (CRP) [Срок оценки: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively]
• Erythrocyte sedimentation rate (ESR) [Срок оценки: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively]
• Interleukin-6 (IL-6) [Срок оценки: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively]
• Total bilirubin (TB) [Срок оценки: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively]
• Derect bilirubin (DB) [Срок оценки: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively]

Критерии участия

Критерии включения

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 hospital.
• 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.

Критерии исключения

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 heart failure, or any acute coronary events within the past 6 months; severe hepatic or renal dysfunction; and pregnancy or lactation.
• Concurrent participation in clinical trials other than this trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Fujian Medical University — Фучжоу

Идентификаторы

NCT: NCT06600815 · MRCTA, ECFAH of FMU|2024]576

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗