Effects of İntraarticular and Periarticular Applied Drugs on Postoperative Pain Management in Artroscopic Knee Surgery for
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 主要终点
- Change in postoperative pain scores throughout time evaluated by VAS
研究概览
简要总结
the aim is to compare the effects of two different doses of intraarticular ketamine on postoperative pain scores and analgesic requirements.in knee artroscopy
详细描述
All pateints are going to be operated under general anesthesia. At the end of the study patients are going to be randomyl seperated into 3 groups. The surgeon is going the following drugs intraarticulary.
Group KL1: 0.5 mg/kg ketamin in % 0..9 NaCl at a total volume of 20 ml Group KL2: 1 mg/kg ketamin in % 0.9 NaCl at a total volume of 20 ml Group SL: 20 ml % 0.9 NaCl ll patients are going to receive a periarticula injection of 10 ml 0.5 bupivacaine and patient controlled analgesia with morphine.
VAS scores and total analgesic requirement is going to be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 接受健康志愿者
- 否
入选标准
- •Artroscopic surgery
排除标准
- •Long time NSAID use
- •Travmatic knee injury
- •Long ter analgesic use
- •Intraartiular catheter insertion at the end of surgery
研究组 & 干预措施
Ketamine 0.5 mg/kg
ketamin 0.5 mg/kg intraarticular
干预措施: Ketamine 0.5 (Drug)
Ketamine 1 mg/kg
ketamin 1 mg/kg intraarticular injection
干预措施: Ketamine 1 (Drug)
% 0.9 Saline
% 0.9 NaCL intraarticular injection
干预措施: % 0.9 NaCl (Drug)
结局指标
主要结局
Change in postoperative pain scores throughout time evaluated by VAS
时间窗: VAS scores at rest and during activity will be evaluated for 24 hours. The first measurement will be recorded immediately after surgery and at 30 minutes interval for the first hour. Afterwards at 2.4.6.12.24.hours postoperatively.
Pain scores are going to be evaluated by VAS scores at rest and VAS scores at activity
Difference in opioid Sparing effect measured through morphine amount delivered by a patient controlled analgesia device.
时间窗: Total amount off delivered morphine will be recorded for 24 hours.
The total amount of morphine delivered by the patient controlled analgesia device in the first 24 hours will be recorded.
次要结局
- Time for discharge measured by eligible for discharge criteria(Discharge criterias will be evaluated every three hours until postoperative 24. hour. In patients who did not complete the discharge criteria in the postoperative 24 hours period, they will be defined as prolonged discharge.)
研究者
Ozlem Sagir, MD
Associated Professor
Balikesir University