Effect of Paracetamol and Ibuprofen When Intravenously Given Combination or Alone in Reducing Morphine Requirements After Total Knee Arthroplasty
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Total morphine requirement
研究概览
简要总结
Adequate pain management has an important role in supporting early ambulation after the Total Knee Arthroplasty (TKA). Multimodal analgesia is one of the modalities of overcoming postoperative pain. The use of combination Paracetamol and Ibuprofen injection is expected to reduce total morphine consumption after TKA.
详细描述
The research will compare the effect of paracetamol injection and ibuprofen injection when given alone or in combination to reduce morphine requirement in a patient after total knee arthroplasty
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The study medication will be masked by the pharmacy. Participants, those administrating the intervention, other caregivers, outcome assessors, data managers, statisticians, and investigators drawing conclusions will be blinded to the intervention.
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patient with 20 < BMI < 30 kg/m2
- •Adult patient with knee varus alignment 10-20°
排除标准
- •Impaired cardiac, liver, and/or renal function.
- •History of substance abuse or chronic pain.
- •Patients are known to be hypersensitive to any of the components of IV ibuprofen or IV paracetamol.
- •Patients currently on anticoagulation medications.
- •Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board) and agree to abide by the study restrictions.
研究组 & 干预措施
Paracetamol+Ibuprofen
Patients in Group 1 will receive a combination of 1000 mg IV paracetamol and 800 mg IV ibuprofen at the end of operation following by 1000 mg IV paracetamol and 800 mg IV ibuprofen every 6 hours up to 72 hours.
干预措施: Paracetamol injection and Ibuprofen injection (Drug)
Paracetamol+normal saline
Patients in Group 2 will receive 1000 mg IV paracetamol and 100 ml IV normal salines at the end of operation following by 1000 mg IV paracetamol and 100 ml IV normal salines every 6 hours up to 72 hours.
干预措施: Paracetamol injection and normal saline (Drug)
Ibuprofen+normal saline
Patients in Group 3 will receive 800 mg IV ibuprofen and 100 ml IV normal salines at the end of operation following by 800 mg IV ibuprofen and 100 ml IV normal salines every 6 hours up to 72 hours.
干预措施: Ibuprofen Injection and normal saline (Drug)
结局指标
主要结局
Total morphine requirement
时间窗: 24 hours
morphine requirement in patient after total knee arthroplasty procedure
次要结局
- Numerical rating scale of pain in resting phase, walking phase, knee full flexion phase(24 hours, 48 hours, 72 hours)
- range of motion knee in flexion and extension(24 hours, 48 hours, 72 hours)
- 2MWT after total knee arthroplasty procedure(24 hours, 48 hours, 72 hours)
研究者
Andri Maruli Tua Lubis
Head of Research Division RSCM
Indonesia University