The Effect of Periarticular Injection of Multi-drug Regimen on Pain in Patient Receiving Partial Hip Replacement:Randomized Prospective Study.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Visual analogue scale 1day
研究概览
简要总结
This prospective randomized study aims to evaluate the effectiveness of periarticular multi-drug regimen injection on the relief of pain in patients undergoing partial hip replacement.
Total 258 patients will be randomized into one of two groups (groupC or groupI) based on Excel number generation.
Patients in group C will receive no medication intraoperatively, and patients in group I will receive oral oxycodone and celecoxib preoperatively and a periarticular injection of multi-drug regimen during operation.
Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 1, 4, 7 postoperative day.
详细描述
Patients in group I will receive oxycodone SR 10 mg, and celecoxib 200 mg with 10 ml of water 1 hour before surgery.
And patients in group I will receive periarticular injection of 50 ml solution which contains ropivacaine 15 mg, epinephrine 0.3 mg, cefmetazole 1000mg, ketorolac 30 mg and morphine HCL 10mg before closure of surgical wound.
Patients in group C will receive no medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •femoral neck fracture
- •partial hip replacement
排除标准
- •r/o infection
- •reoperation
- •mental change
研究组 & 干预措施
control group (group C)
control group will receive no medication preoperatively and during operation
干预措施: none of medication preoperatively and intraoperatively (Drug)
periarticular injecion group (group I)
patients in Group I will receive oral oxycodone SR 10 mg and celecoxib 200 mg 1 hour preoperatively with sips of water, and receive periarticular injection of combination of ropivacaine 15 mg, morphine 10 mg, ketorolac 30 mg epinephrine 0.3 mg and cefmetazole 1000mg during operation.
干预措施: periarticular injection of multidrug regimen (Drug)
结局指标
主要结局
Visual analogue scale 1day
时间窗: Post Op 1 day
Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. To check the severity of pain VAS will be measured at post op 1day.
次要结局
- Opioid consumption 1day(Post Op 1 day)
- FPB 1day(Post Op 1 day)
- delirium rating scale at admission(at admission)
- Visual Analogue Scale 4day(Post OP 4day)
- Visual Analogue Scale 7day(Post Op 7day)
- Opioid consumption 4day(Post Op 4 day)
- Opioid consumption 7day(Post Op 7 day)
- FPB 4day(Post Op 4 day)
- FPB 7day(Post Op 7 day)
- delirium rating scale 1day(Post Op 1day)
- delirium rating scale 4day(Post Op 4day)
- delirium rating scale 7day(Post Op 7day)