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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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). 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.

Conditions

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Total Knee Arthroplasty Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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preemptive stepwise infiltration anaesthesia(PSIA) group

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 \[calculated as betamethasone\]).

Group Type EXPERIMENTAL

preemptive stepwise infiltration anaesthesia(PSIA)

Intervention Type 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.

postoperative local infiltration analgesia(PLIA) group

Drugs: the same preoperative preparation and treatment with the anaesthesia cocktail formulation as those in the PSIA group.

Group Type ACTIVE_COMPARATOR

postoperative local infiltration analgesia(PLIA)

Intervention Type 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.

Interventions

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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 the posterior joint capsule after bone resection.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes