NCT06600815

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

Analgesic Efficacy of Preemptive Stepwise Infiltration Anesthesia for Perioperative Analgesia After Total Knee Arthroplasty: a Prospective Double-blind Randomized Controlled Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: First Affiliated Hospital of Fujian Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Total Knee Arthroplasty
• Pain Management

Interventions

Type	Name	Description
PROCEDURE	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.
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.

Timeline

• Start date: 2024-09-30
• Primary completion: 2025-10-01
• Completion: 2025-12-01
• First posted: 2024-09-19
• Last updated: 2024-10-17

Locations

1 site across 1 country: China