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

Not Applicable

Recruiting

• Conditions: Total Knee Arthroplasty; Pain Management
• Interventions: Procedure: preemptive stepwise infiltration anaesthesia(PSIA); Procedure: postoperative local infiltration analgesia(PLIA)

• Registration Number: NCT06600815
• Lead Sponsor: First Affiliated Hospital of Fujian Medical University

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.

Study Timeline

• Study First Submitted: 2024-08-02
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-17
• Study First Posted: 2024-09-19
• Study Start: 2024-09-30
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-17
• Primary Completion: 2025-10
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
preemptive stepwise infiltration anaesthesia(PSIA) group	preemptive stepwise infiltration anaesthesia(PSIA)	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 \[calculated as betamethasone\]).
postoperative local infiltration analgesia(PLIA) group	postoperative local infiltration analgesia(PLIA)	Drugs: the same preoperative preparation and treatment with the anaesthesia cocktail formulation as those in the PSIA group.

Primary Outcome Measures

Name	Time	Method
Postoperative morphine consumption within the first 24 hours	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	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative time to first rescue analgesia	up to 3 days	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.
Total morphine consumption during hospitalization	through study completion, an average of 6 months	It will be converted to total morphine equivalents and will include both the postoperative routine pain management regimen and rescue analgesia.
The Hospital for Special Surgery Knee Score (HSS)	3 weeks, 6 weeks and 6 months postoperatively	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.
Range of motion (ROM)	3 weeks, 6 weeks and 6 months postoperatively	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.
Direct intraoperative bleeding	24 hours postoperatively	Intraoperative bleeding will be recorded directly by anesthesiologists (mL).
Indirect intraoperative bleeding	24 hours postoperatively	Intraoperative bleeding will be estimated by subtracting the preoperative hemoglobin level from the hemoglobin level measured 24 hours postoperatively.
Complete blood count	72 hours, 3 weeks, 6 weeks and 6 months postoperatively	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.
C-reactive protein (CRP)	72 hours, 3 weeks, 6 weeks and 6 months postoperatively	C-reactive protein (CRP) can reflect the patient's postoperative inflammatory status.
Erythrocyte sedimentation rate (ESR)	72 hours, 3 weeks, 6 weeks and 6 months postoperatively	Erythrocyte sedimentation rate (ESR) can reflect the patient's postoperative inflammatory status.
Interleukin-6 (IL-6)	72 hours, 3 weeks, 6 weeks and 6 months postoperatively	Interleukin-6 (IL-6) can reflect the patient's postoperative inflammatory status.
Total bilirubin (TB)	72 hours, 3 weeks, 6 weeks and 6 months postoperatively	Total bilirubin will be used to evaluate the impacts of surgical trauma and medications on patients.
Derect bilirubin (DB)	72 hours, 3 weeks, 6 weeks and 6 months postoperatively	Derect bilirubin will be used to evaluate the impacts of surgical trauma and medications on patients.
Aspartate aminotransferase (AST)	72 hours, 3 weeks, 6 weeks and 6 months postoperatively	Aspartate aminotransferase will be used to evaluate the impacts of surgical trauma and medications on patients.
Alanine aminotransferase (ALT)	72 hours, 3 weeks, 6 weeks and 6 months postoperatively	Alanine aminotransferase will be used to evaluate the impacts of surgical trauma and medications on patients.
Creatinine (Cr)	72 hours, 3 weeks, 6 weeks and 6 months postoperatively	Creatinine will be used to evaluate the impacts of surgical trauma and medications on patients.

Trial Locations

Locations (1)

The First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China