Analgesic Efficacy of Preemptive Stepwise Infiltration Anesthesia for Perioperative Analgesia After Total Knee Arthroplasty: a Prospective Double-blind Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Postoperative morphine consumption within the first 24 hours
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The researchers, outcome assessors and statisticians will be blinded to the group assignments and will not be involved in the trial operations. The patients will also be blinded to the group assignments. Due to the impossibility of blinding the surgeons, they will not be involved in any outcome assessments. Allocation results will be placed in sealed envelopes before the surgery. The envelopes will be opened prior to surgery after the administration of general anaesthesia.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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.
排除标准
- •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.
结局指标
主要结局
Postoperative morphine consumption within the first 24 hours
时间窗: the first 24 hours after TKA
Postoperative morphine consumption within the first 24 hours includes both routine analgesia and rescue analgesia, which will be converted to oral morphine equivalents (OMEs)
. Postoperative visual analogue scale (VAS) scores at 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, 3 weeks, 6 weeks and 6 months
时间窗: 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, 3 weeks, 6 weeks and 6 months after TKA
VAS scores are the most commonly used indicator for assessing the intensity of patient pain (15). The scale ranges from "0" to "10", where "0" indicates no pain and "10" represents the most severe pain that is unbearable. Patients will rate their pain based on subjective perceptions. In this trial, VAS scores will be recorded once before TKA. The VAS scores will be assessed separately for the resting and flexion states. If the patient's hospitalization period is shorter than 72 hours, the VAS score at discharge will be recorded instead of that at 72 hours. Studies have shown that some patients still experience joint pain six months after TKA. The VAS scores of patients at 6 months after TKA will be evaluated. A VAS score of 4 or above is defined as "chronic persistent pain after TKA." The results will be used to evaluate whether PSIA can reduce pain after TKA.
次要结局
- Postoperative time to first rescue analgesia(up to 3 days)
- Total morphine consumption during hospitalization(through study completion, an average of 6 months)
- The Hospital for Special Surgery Knee Score (HSS)(3 weeks, 6 weeks and 6 months postoperatively)
- Range of motion (ROM)(3 weeks, 6 weeks and 6 months postoperatively)
- Direct intraoperative bleeding(24 hours postoperatively)
- Indirect intraoperative bleeding(24 hours postoperatively)
- Complete blood count(72 hours, 3 weeks, 6 weeks and 6 months postoperatively)
- C-reactive protein (CRP)(72 hours, 3 weeks, 6 weeks and 6 months postoperatively)
- Erythrocyte sedimentation rate (ESR)(72 hours, 3 weeks, 6 weeks and 6 months postoperatively)
- Interleukin-6 (IL-6)(72 hours, 3 weeks, 6 weeks and 6 months postoperatively)
- Total bilirubin (TB)(72 hours, 3 weeks, 6 weeks and 6 months postoperatively)
- Derect bilirubin (DB)(72 hours, 3 weeks, 6 weeks and 6 months postoperatively)
- Aspartate aminotransferase (AST)(72 hours, 3 weeks, 6 weeks and 6 months postoperatively)
- Alanine aminotransferase (ALT)(72 hours, 3 weeks, 6 weeks and 6 months postoperatively)
- Creatinine (Cr)(72 hours, 3 weeks, 6 weeks and 6 months postoperatively)
研究者
Xinyu Fang
Deputy chief physician
First Affiliated Hospital of Fujian Medical University