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临床试验/NCT06555458
NCT06555458已完成不适用

The Effect of Sedation on Rebound Pain in Knee Arthrplasty Performed Under Spinal Anesthesia

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2023年11月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
1
主要终点
Rebound pain VAS scores and incidence of rebound pain

研究概览

简要总结

Dexmedetomidine is often used for sedation procedures. It has also been shown to have a pain-protective effect. Researchers predicted that using dexmedetomidine for sedation in total knee arthroplasties performed under spinal anesthesia would reduce the frequency of rebound pain and pain scores.

详细描述

Randomization will take place before the patient enters the operating room. After spinal anesthesia is applied, 0.4 mcg/kg sedadomide loading will be done for 10 minutes in the sedation group, and then 0.4 mcg/kg/h sedadomide infusion will continue until the end of the surgery. Patients selected for the control group will be given the same amounts of saline. At the end of the surgical procedure, saline and sedadomide infusions will be stopped. All patients will undergo an adductor canal block under USG guidance in the recovery room. 50 mg of buvacin will be given to the block area. Patients will be fitted with a patient control analgesia device, which only provides bolus application and provides 20 mg of madol in each bolus. Postoperatively, sudden onset severe withdrawal pain outside the normal course of pain starting within 48 hours will be followed and Vas-bromage monitoring will be done at 0, 1, 2, 4, 8, 12, 24, 36, 48 hours.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Total Knee arthroplasty American Society of Anesthesiologist score of 1-3 Age 18-85 Elective total knee arthroplasty under spinal anesthetic.

排除标准

  • Situations in which spinal anesthesia is contraindicated
  • Advanced organ failure states(cardiac,hepatic,respiratuar or renal)
  • Pregnancy
  • BMI > 40 kg/m^2
  • Do not want to participate in the study
  • Younger than 18 or older than 85
  • Have bilateral total knee arthroplasty or resurgery
  • Develop an unexpected intraoperative surgical complication

结局指标

主要结局

Rebound pain VAS scores and incidence of rebound pain

时间窗: 48 hours after surgery

Rebound pain-defined as transient acute postoperative pain within 12-24hrs that ensues following resolution of sensory blocked.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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