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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| preemptive stepwise infiltration anaesthesia(PSIA) group | Experimental | Drugs：A cocktail of anaesthetics (30 mg of ropivacaine, 0.3 mg of adrenaline) will be prepared, diluted with normal saline to 120 mL, and divided into two equal parts(Cocktail A[CA] and Cocktail B[CB]), with CB containing 8 mg of added betamethasone (each 1 ml of the compound contains 5 mg betamethasone dipropionate [calculated as betamethasone] and 2 mg of betamethasone sodium phosphate [calculated as betamethasone]). |
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| postoperative local infiltration analgesia(PLIA) group | Active Comparator | Drugs: the same preoperative preparation and treatment with the anaesthesia cocktail formulation as those in the PSIA group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| preemptive stepwise infiltration anaesthesia(PSIA) | Procedure | 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 the posterior joint capsule after bone resection. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative morphine consumption within the first 24 hours | Postoperative morphine consumption within the first 24 hours includes both routine analgesia and rescue analgesia, which will be converted to oral morphine equivalents (OMEs) | 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 | 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. | 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, 3 weeks, 6 weeks and 6 months after TKA |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative time to first rescue analgesia | Rescue analgesia will be initiated when the patient reports local knee joint pain on the operative side with a VAS score > 4. The specific steps will be implemented as described previously. The time to rescue analgesia will be recorded. | up to 3 days |
| Total morphine consumption during hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| Age | Age in years will be obtained from the electronic medical records system. | through study completion, an average of 6 months |
| Sex | Sex (male or female) will be obtained from the electronic medical records system. |
Inclusion Criteria:
Patients must meet all of the following criteria to be eligible for inclusion:
Exclusion Criteria:
Patients will be excluded if they meet any of the following criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinyu Fang, MD | Contact | 18084768503 Ext. 86 | 9738006@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Wenming Zhang, MD | First Affiliated Hospital of Fujian Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Fujian Medical University | Recruiting | Fuzhou | Fujian | China |
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The trial employs a random allocation method. A randomization table will be generated using SPSS 26.0 software. Treatment groups will be selected based on patients' random numbers, ensuring that this clinical institution stratifies the subjects into a PSIA group and a PLIA group at a 1:1 ratio.
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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.
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| postoperative local infiltration analgesia(PLIA) | Procedure | 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. |
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It will be converted to total morphine equivalents and will include both the postoperative routine pain management regimen and rescue analgesia. |
| through study completion, an average of 6 months |
| The Hospital for Special Surgery Knee Score (HSS) | The Hospital for Special Surgery Knee Score (HSS) is a patient-reported questionnaire specific to the knee joint, with a total score of 100 points. It comprises six scoring components: pain (30 points), function (22 points), range of motion (18 points), muscle strength (10 points), knee deformity (10 points) and stability (10 points). Additional points are deducted for the use of assistive devices, extension lag and varus deformity: up to 3 points for assistive device use, up to 5 points for extension lag and 1 point deducted for every 5 degrees of varus deformity. The scores are classified as follows: ≥ 85 as "Excellent", 70-84 as "Good", 60-69 as "Fair", and < 60 as "Poor". The HSS score is widely praised for its perceived ease of use and quick recording and has been shown to be an effective and reliable measure for assessing the efficacy of TKA. | 3 weeks, 6 weeks and 6 months postoperatively |
| Range of motion (ROM) | The range of motion (ROM) will be measured with a protractor thrice daily at 6-hour intervals, and the best value on each day will be used in the analysis. The range of motion (ROM) is from 0 to 180 degrees. The larger the angle, the more satisfactory the recovery of joint function. | 3 weeks, 6 weeks and 6 months postoperatively |
| Direct intraoperative bleeding | Intraoperative bleeding will be recorded directly by anesthesiologists (mL). | 24 hours postoperatively |
| Indirect intraoperative bleeding | Intraoperative bleeding will be estimated by subtracting the preoperative hemoglobin level from the hemoglobin level measured 24 hours postoperatively. | 24 hours postoperatively |
| Complete blood count | A complete blood count (CBC) can reflect the patient's postoperative inflammatory status. It measures various components of the blood, including white blood cells, red blood cells, and platelets, which can indicate the presence of inflammation or infection. An elevated white blood cell count, for example, is often associated with an inflammatory response. | 72 hours, 3 weeks, 6 weeks and 6 months postoperatively |
| C-reactive protein (CRP) | C-reactive protein (CRP) can reflect the patient's postoperative inflammatory status. | 72 hours, 3 weeks, 6 weeks and 6 months postoperatively |
| Erythrocyte sedimentation rate (ESR) | Erythrocyte sedimentation rate (ESR) can reflect the patient's postoperative inflammatory status. | 72 hours, 3 weeks, 6 weeks and 6 months postoperatively |
| Interleukin-6 (IL-6) | Interleukin-6 (IL-6) can reflect the patient's postoperative inflammatory status. | 72 hours, 3 weeks, 6 weeks and 6 months postoperatively |
| Total bilirubin (TB) | Total bilirubin will be used to evaluate the impacts of surgical trauma and medications on patients. | 72 hours, 3 weeks, 6 weeks and 6 months postoperatively |
| Derect bilirubin (DB) | Derect bilirubin will be used to evaluate the impacts of surgical trauma and medications on patients. | 72 hours, 3 weeks, 6 weeks and 6 months postoperatively |
| Aspartate aminotransferase (AST) | Aspartate aminotransferase will be used to evaluate the impacts of surgical trauma and medications on patients. | 72 hours, 3 weeks, 6 weeks and 6 months postoperatively |
| Alanine aminotransferase (ALT) | Alanine aminotransferase will be used to evaluate the impacts of surgical trauma and medications on patients. | 72 hours, 3 weeks, 6 weeks and 6 months postoperatively |
| Creatinine (Cr) | Creatinine will be used to evaluate the impacts of surgical trauma and medications on patients. | 72 hours, 3 weeks, 6 weeks and 6 months postoperatively |
| through study completion, an average of 6 months |
| Operative site | Operative site (left or right) will be obtained from the electronic medical records system. | through study completion, an average of 6 months |
| BMI | Weight (kg) and height (m) will be combined to report BMI in kg/m^2, which will be obtained from the electronic medical records system. This information will be collected by the same evaluator and used to calculate the age-corrected Charlson Comorbidity Index (aCCI), baseline ROM, HSS score and VAS score for these patients. | through study completion, an average of 6 months |
| Time of operation | Inpatient data will include the operative time and time to discharge. These inpatient data will be sourced from the electronic medical records system and used to evaluate the impacts of PSIA and PLIA on the surgical process and postoperative recovery. | through study completion, an average of 6 months |
| Operative time | Operative time will be sourced from the electronic medical records system and used to evaluate the impacts of PSIA and PLIA on the surgical process and postoperative recovery. | through study completion, an average of 6 months |
| Time to discharge | Time to discharge will be sourced from the electronic medical records system and used to evaluate the impacts of PSIA and PLIA on the surgical process and postoperative recovery. | through study completion, an average of 6 months |
| Incidence of Adverse events (AEs) | Adverse events (AEs) are adverse medical events that occur in clinical trial subjects after receiving treatment. In this study, total AEs will be mainly categorized into local AEs and systemic AEs. Local AEs include but are not limited to prolonged wound drainage (wound drainage persists on postoperative day 3, and the drainage area of the wound dressing is greater than 2×2 cm , poor wound healing and prosthetic joint infection. Systemic AEs include but are not limited to deep vein thrombosis events, systemic infection and serious adverse events such as pulmonary embolism and death. | through study completion, an average of 6 months |
| Likert score | We will use a Likert scale to evaluate participants satisfaction with each treatment phase at each assessment. This scale consists of 5 levels (very dissatisfied, dissatisfied, neutral, satisfied and very satisfied) from 1 to 5. After the final follow-up, the total score on the Likert scale for each participant will represent their overall satisfaction to date. The larger the score, the more satisfactory with the participants. | through study completion, an average of 6 months |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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