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To evaluate the efficacy and safety of different doses of triamcinolone for local infiltration analgesia during total knee replacement
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | LIA preparation was administered without triamcinolone. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml. |
|
| Low dose triamcinolone | Experimental | Add 20mg triamcinolone to the LIA preparation. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml. |
|
| Moderate dose triamcinolone | Experimental | add 40mg triamcinolone to the LIA preparation. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml. |
|
| High dose triamcinolone | Experimental | add 80mg triamcinolone to the LIA preparation. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| without triamcinolone | Drug | The preparation contains only the basic formula. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tian Hua, doctor | Director | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality | 100181 | China |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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An independent researcher, who would not meet or interact with patients before recruiting them, compiled a computer-generated randomised list using a 1:1:1:1 assignment and random blocks of 12, 8 or 4 to ensure the concealability of the assignment. The groups corresponding to the numbers generated by the random number generator were placed in opaque envelopes and sealed, and the enrolled patients were assigned envelopes in the chronological order in which they were enrolled.
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An independent researcher, who would not meet or interact with patients before recruiting them, compiled a computer-generated randomised list using 1:1 assignments and random blocks of 8, 6 or 4 to ensure the invisibility of assignments. The groups corresponding to the numbers generated by the random number generator were placed in opaque envelopes and sealed, and the enrolled patients were assigned envelopes in the chronological order in which they were enrolled. On the day of surgery, the anesthesiologist prepares to mix the drug preparation after opening the sealed envelope, which is then handed to the operating room nurse. The patient, the rehabilitation physician, and the ward nurse did not know the type of drug mixture the patient was injected with.
|
| 20mg triamcinolone | Drug | 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 | Drug | 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 | Drug | 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. |
|
|
| 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 |
| Postoperative day 2 |
| Blood routine | Assay index including white blood cell count and neutrophil count. | Postoperative day 3 |
| 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 |
| 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 |
| D012216 |
| Rheumatic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |