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临床试验/NCT05997238
NCT05997238已完成4 期

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

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年4月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
120
试验地点
1
主要终点
pain visual analogue scale score

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: without triamcinolone (Drug)

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.

干预措施: 20mg triamcinolone (Drug)

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.

干预措施: 40mg triamcinolone (Drug)

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.

干预措施: 80mg triamcinolone (Drug)

结局指标

主要结局

pain visual analogue scale score

时间窗: 12 weeks after surgery

pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect

次要结局

  • Blood routine(Postoperative day 3)
  • Complication rate(Three months after surgery)
  • Test index of drainage liquefaction(Postoperative day 1)
  • Knee range of motion(Postoperative day 3)
  • The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index(Three months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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