Clinical trial NCT06600815: Analgesic Efficacy of Preemptive Stepwise Infiltration Anesthesia for Perioperative Analgesia After TKA
Official title: Analgesic Efficacy of Preemptive Stepwise Infiltration Anesthesia for Perioperative Analgesia After Total Knee Arthroplasty: a Prospective Double-blind Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Total Knee Arthroplasty
Pain Management
Keywords: Total knee arthroplasty
Pain management
Anaesthesia in orthopaedics
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: 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.

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.

Primary outcomes:
measure: Postoperative morphine consumption within the first 24 hours
timeFrame: the first 24 hours after TKA
measure: . Postoperative visual analogue scale (VAS) scores at 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, 3 weeks, 6 weeks and 6 months
timeFrame: 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, 3 weeks, 6 weeks and 6 months after TKA
Secondary outcomes:
measure: Postoperative time to first rescue analgesia
timeFrame: up to 3 days
measure: Total morphine consumption during hospitalization
timeFrame: through study completion, an average of 6 months
measure: The Hospital for Special Surgery Knee Score (HSS)
timeFrame: 3 weeks, 6 weeks and 6 months postoperatively
measure: Range of motion (ROM)
timeFrame: 3 weeks, 6 weeks and 6 months postoperatively
measure: Direct intraoperative bleeding
timeFrame: 24 hours postoperatively
measure: Indirect intraoperative bleeding
timeFrame: 24 hours postoperatively
measure: Complete blood count
timeFrame: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively
measure: C-reactive protein (CRP)
timeFrame: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively
measure: Erythrocyte sedimentation rate (ESR)
timeFrame: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively
measure: Interleukin-6 (IL-6)
timeFrame: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively
measure: Total bilirubin (TB)
timeFrame: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively
measure: Derect bilirubin (DB)
timeFrame: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively
measure: Aspartate aminotransferase (AST)
timeFrame: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively
measure: Alanine aminotransferase (ALT)
timeFrame: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively
measure: Creatinine (Cr)
timeFrame: 72 hours, 3 weeks, 6 weeks and 6 months postoperatively
Other outcomes:
measure: Age
timeFrame: through study completion, an average of 6 months
measure: Sex
timeFrame: through study completion, an average of 6 months
measure: Operative site
timeFrame: through study completion, an average of 6 months
measure: BMI
timeFrame: through study completion, an average of 6 months
measure: Time of operation
timeFrame: through study completion, an average of 6 months
measure: Operative time
timeFrame: through study completion, an average of 6 months
measure: Time to discharge
timeFrame: through study completion, an average of 6 months
measure: Incidence of Adverse events (AEs)
timeFrame: through study completion, an average of 6 months
measure: Likert score
timeFrame: through study completion, an average of 6 months
Locations:
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
affiliation: First Affiliated Hospital of Fujian Medical University
name: Wenming Zhang, MD
role: STUDY_DIRECTOR
References: