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

NCT06600815 | Recruiting

• 1 other identifier: MRCTA, ECFAH of FMU|2024]576
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty; Pain Management

Keywords

Total knee arthroplasty; Pain management; Anaesthesia in orthopaedics

Outcome Measures

Primary Outcomes (2)

• Postoperative morphine consumption within the first 24 hours

  Postoperative morphine consumption within the first 24 hours includes both routine analgesia and rescue analgesia, which will be converted to oral morphine equivalents (OMEs)

  the first 24 hours after TKA

• . Postoperative visual analogue scale (VAS) scores at 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, 3 weeks, 6 weeks and 6 months

  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.

  6 hours, 12 hours, 24 hours, 48 hours, 72 hours, 3 weeks, 6 weeks and 6 months after TKA

Secondary Outcomes (15)

• Postoperative time to first rescue analgesia

  up to 3 days

• Total morphine consumption during hospitalization

  through study completion, an average of 6 months

• The Hospital for Special Surgery Knee Score (HSS)

  3 weeks, 6 weeks and 6 months postoperatively

• Range of motion (ROM)

  3 weeks, 6 weeks and 6 months postoperatively

• Direct intraoperative bleeding

  24 hours postoperatively

Other Outcomes (9)

• Age

  through study completion, an average of 6 months

• Sex

  through study completion, an average of 6 months

• Operative site

  through study completion, an average of 6 months

Study Arms (2)

preemptive stepwise infiltration anaesthesia(PSIA) group

EXPERIMENTAL

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 \[calculated as betamethasone\]).

Procedure: preemptive stepwise infiltration anaesthesia(PSIA)

postoperative local infiltration analgesia(PLIA) group

ACTIVE COMPARATOR

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

Procedure: postoperative local infiltration analgesia(PLIA)

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.

preemptive stepwise infiltration anaesthesia(PSIA) group

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.

postoperative local infiltration analgesia(PLIA) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Preoperative American Society of Anaesthesiologists (ASA) score ranging from 1 to 3. Surgeons deemed the patient eligible for TKA based on the evaluation criteria.
• Participants aged 18 years or older, both male and female.
• Ability to provide informed consent and sign a written informed consent form.
• The ability to comprehend the research requirements and willingness to cooperate with the study instructions.

You may not qualify if:

• Patients will be excluded if they meet any of the following criteria:
• Previous knee surgery on the operative knee or a history of infection in the operative knee.
• Patients diagnosed with conditions other than osteoarthritis (including rheumatoid arthritis, traumatic arthritis, septic arthritis and haemophilic arthritis).
• Severe osteoarthritis (including flexion contracture \>30° or varus/valgus deformity \>30° and the use of unconventional arthroplasty components due to complex joint pathology \[e.g., restrictive prostheses\]).
• Allergy to the investigational drug.
• The presence of neuromuscular dysfunction on the operative side.
• 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).
• 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.
• Concurrent participation in clinical trials other than this trial.

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wenming Zhang, MD

  First Affiliated Hospital of Fujian Medical University

  STUDY DIRECTOR

Central Study Contacts

Xinyu Fang, MD

CONTACT

18084768503 Ext. 86; 9738006@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief physician

Model Details: 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.

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: September 19, 2024
• Study Start: September 30, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 17, 2024

Record last verified: 2024-09

Locations

CN (1)