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

Osteoarthritis, Knee Clinical Trial

— LIA;TKA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05997238
• Other study ID #: Triamcinolone68480
• Status: Completed
• Phase: Phase 4
• Start date: April 25, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: April 2023
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 1, 2024
• Est. primary completion date: February 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	Blood routine	Assay index including white blood cell count and neutrophil count.	Postoperative day 1
Secondary	Blood routine	Assay index including white blood cell count and neutrophil count.	Postoperative day 2
Secondary	Blood routine	Assay index including white blood cell count and neutrophil count.	Postoperative day 3
Secondary	Test index of drainage liquefaction	Assay index	Postoperative day 1
Secondary	Complication rate	Follow-up visit	Three months after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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