Peking University Third Hospital
Beijing, Beijing Municipality, 100181, China
NCT Number: NCT05997238
To evaluate the efficacy and safety of different doses of triamcinolone for local infiltration analgesia during total knee replacement
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Notify Me50 year–85 year
All sexes
Interventional
Phase 4
Beijing, Beijing Municipality, 100181, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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
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
Time frame: 2 hours after surgery
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
Time frame: 4 hours after surgery
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
Time frame: 8 hours after surgery
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
Time frame: 24 hours after surgery
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
Time frame: 48 hours after surgery
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
Time frame: 72 hours after surgery
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
Time frame: 2 weeks after surgery
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
Time frame: 4 weeks after surgery
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
Time frame: 8 weeks after surgery
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
Time frame: 12 weeks after surgery
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
Time frame: Postoperative day 1
Assay index including white blood cell count and neutrophil count.
Time frame: Postoperative day 2
Assay index including white blood cell count and neutrophil count.
Time frame: Postoperative day 3
Assay index including white blood cell count and neutrophil count.
Time frame: Postoperative day 1
Assay index
Time frame: Three months after surgery
Follow-up visit
Time frame: 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
Time frame: Postoperative day 1
The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery
Time frame: Postoperative day 2
The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery
Time frame: Postoperative day 3
The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery
Peking University Third Hospital
Other
Evaluation of the Effect of Triamcinolone at Different Doses on Local Infiltration Anesthesia During Total Knee Arthroplasty
Acronym: LIA;TKA
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