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

Sponsor
First Affiliated Hospital of Fujian Medical University
Study ID
NCT06600815
Status
Recruiting
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Conditions

  • Pain Management
  • Total Knee Arthroplasty

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

First listed
Sep 19, 2024
Start date
Sep 30, 2024
Status verified
Sep 2024
Primary completion
Oct 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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 \[calculated as betamethasone\]).
  • Active Comparator: postoperative local infiltration analgesia(PLIA) group
    Drugs: the same preoperative preparation and treatment with the anaesthesia cocktail formulation as those in the PSIA group.

Primary Outcome Measure

Postoperative morphine consumption within the first 24 hours [ Time Frame: the first 24 hours after TKA ]

Central Contacts

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