Evaluation of the Effect of Triamcinolone at Different Doses on LIA During TKA (LIA;TKA)

Evaluation of the Effect of Triamcinolone at Different Doses on Local Infiltration Anesthesia During Total Knee Arthroplasty

To evaluate the efficacy and safety of different doses of triamcinolone for local infiltration analgesia during total knee replacement

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Drug: without triamcinolone; Drug: 20mg triamcinolone; Drug: 40mg triamcinolone; Drug: 80mg triamcinolone

Detailed Description

Participants were enrolled according to protocol requirements. Patients who meet all inclusion criteria and do not have any exclusion criteria will be considered for inclusion in the study and will provide the relevant information used orally and in writing. Patients were divided into four groups according to the dose of triamcinolone in the peripheral infiltrating anesthetic preparation. All of which are appropriate for their surgical treatment, and the purpose of the study is to determine which formula is clinically better. All patients enrolled in this study were voluntary participants and signed informed consent. On the day of the surgery, the anesthesiologist prepares a mixture of medications based on patient groups, which are then handed to the operating room nurse. The timing, dose, and site of injection were consistent. Before the prosthesis is installed, the mixture is injected into the upper part of the patella, the posterior joint capsule, and the patellar tendon. After the prosthesis was installed, the mixture was injected into the lateral joint capsule and subcutaneous tissue. The patient, the rehabilitation physician, and the ward nurse did not know the type of mixed drug preparation injected by the patient.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Tian Hua, doctor; Phone Number: 86-18811185091; Email: tianhua@bjmu.edu.cn
• Study Contact Backup: Name: Zheng Yuhang, bachelor; Phone Number: 86-18810107656; Email: 1710301104@pku.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100181
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

patients with knee osteoarthritis requiring primary unilateral total knee replacement

Description

Inclusion Criteria:

1. age in the range of 50 to 85 years old
2. patients with knee osteoarthritis requiring primary unilateral total knee replacement
3. the body mass index in the range of 18 to 36 kg/m2
4. possess the physical status I-III of American Society of Anesthesiologists
5. the patient and his family members agree and sign the informed consent

Exclusion Criteria:

1. Non-osteoarthritis (rheumatoid arthritis, traumatic arthritis, septicemic arthritis, etc.)
2. History of knee surgery or knee injury, such as high tibial osteotomy, meniscus repair, ligament reconstruction, etc
3. Flexion deformity ≥30°, internal and external varus deformity ≥15°
4. People allergic to the drugs used in this study
5. Patients who had used glucocorticoids within 3 months before surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; LIA preparation was administered without triamcinolone. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml.	Drug: without triamcinolone; The preparation contains only the basic formula. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml.; Other Names: Placebo
Experimental: Low dose triamcinolone; Add 20mg triamcinolone to the LIA preparation. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml.	Drug: 20mg triamcinolone; 20mg triamcinolone was added to the preparation. Mix 20mg triamcinolone and the basic formula to make a mixed preparation. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml.; Other Names: Low dose triamcinolone
Experimental: Moderate dose triamcinolone; add 40mg triamcinolone to the LIA preparation. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml.	Drug: 40mg triamcinolone; 40mg triamcinolone was added to the preparation. Mix 40mg triamcinolone and the basic formula to make a mixed preparation. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml.; Other Names: Moderate dose triamcinolone
Experimental: High dose triamcinolone; add 80mg triamcinolone to the LIA preparation. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml.	Drug: 80mg triamcinolone; 80mg triamcinolone was added to the preparation. Mix 80mg triamcinolone and the basic formula to make a mixed preparation. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml.; Other Names: High dose triamcinolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee range of motion	The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery	Postoperative day 1
Knee range of motion	The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery	Postoperative day 2
Knee range of motion	The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery	Postoperative day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test index of drainage liquefaction	Assay index	Postoperative day 1
Complication rate	Follow-up visit	Three months after surgery
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index	The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; range from 0 to 100; A higher score indicates better knee function	Three months after surgery
pain visual analogue scale score	pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect	2 hours after surgery
pain visual analogue scale score	pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect	4 hours after surgery
pain visual analogue scale score	pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect	8 hours after surgery
pain visual analogue scale score	pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect	24 hours after surgery
pain visual analogue scale score	pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect	48 hours after surgery
pain visual analogue scale score	pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect	72 hours after surgery
pain visual analogue scale score	pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect	2 weeks after surgery
pain visual analogue scale score	pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect	4 weeks after surgery
pain visual analogue scale score	pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect	8 weeks after surgery
pain visual analogue scale score	pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect	12 weeks after surgery
Blood routine	Assay index including white blood cell count and neutrophil count.	Postoperative day 1
Blood routine	Assay index including white blood cell count and neutrophil count.	Postoperative day 2
Blood routine	Assay index including white blood cell count and neutrophil count.	Postoperative day 3

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Chair: Tian Hua, doctor, Director

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2023
• Primary Completion (Actual): February 12, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: May 17, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 24, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: triamcinolone; total knee arthroplasty; local infiltration anesthesia
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: Triamcinolone68480

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No