LIA;TKA: Evaluation of the Effect of Triamcinolone at Different Doses on LIA During TKA
Study Details
Study Description
Brief Summary
To evaluate the efficacy and safety of different doses of triamcinolone for local infiltration analgesia during total knee replacement
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 two 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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| low-dose triamcinolone group add 40mg triamcinolone to the LIA preparation |
Drug: 40mg triamcinolone
40mg triamcinolone was added to the preparation
|
| high-dose triamcinolone group add 80mg triamcinolone to the LIA preparation |
Drug: 80mg triamcinolone
80mg triamcinolone was added to the preparation
|
Outcome Measures
Primary Outcome Measures
- Knee range of motion [Postoperative day 1]
The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery
- Knee range of motion [Postoperative day 2]
The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery
- Knee range of motion [Postoperative day 3]
The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery
Secondary Outcome Measures
- Blood routine [Postoperative day 1]
Assay index
- Blood routine [Postoperative day 2]
Assay index
- Blood routine [Postoperative day 3]
Assay index
- Test index of drainage liquefaction [Postoperative day 1]
Assay index
- Complication rate [Three months after surgery]
Follow-up visit
- The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index [Three months after surgery]
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; range from 0 to 100; A higher score indicates better knee function
- Morphine intake in 48 hours after surgery [48 hours after surgery]
The patient's use of additional analgesic drugs was recorded through the doctor's order system and converted to morphine equivalent
- pain visual analogue scale score [2 hours after surgery]
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
- pain visual analogue scale score [4 hours after surgery]
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
- pain visual analogue scale score [8 hours after surgery]
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
- pain visual analogue scale score [24 hours after surgery]
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
- pain visual analogue scale score [48 hours after surgery]
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
- pain visual analogue scale score [72 hours after surgery]
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
- pain visual analogue scale score [2 weeks after surgery]
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
- pain visual analogue scale score [4 weeks after surgery]
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
- pain visual analogue scale score [8 weeks after surgery]
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
- pain visual analogue scale score [12 weeks after surgery]
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
Eligibility Criteria
Criteria
Inclusion Criteria:
-
age in the range of 50 to 85 years old
-
patients with knee osteoarthritis requiring primary unilateral total knee replacement
-
the body mass index in the range of 18 to 36 kg/m2
-
possess the physical status I-III of American Society of Anesthesiologists
-
the patient and his family members agree and sign the informed consent
Exclusion Criteria:
-
Non-osteoarthritis (rheumatoid arthritis, traumatic arthritis, septicemic arthritis, etc.)
-
History of knee surgery or knee injury, such as high tibial osteotomy, meniscus repair, ligament reconstruction, etc
-
Flexion deformity ≥30°, internal and external varus deformity ≥15°
-
People allergic to the drugs used in this study
-
Patients who had used glucocorticoids within 3 months before surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University Third Hospital | Beijing | Beijing | China | 100181 |
Sponsors and Collaborators
- Peking University Third Hospital
Investigators
- Study Chair: Tian Hua, doctor, Director
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Triamcinolone68480