A randomized controlled trial on the effect of different intraoperative tourniquet pressure on postoperative pain and complications after total knee replacement
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- VAS score for pain
研究概览
简要总结
Study is being done to compare the functional outcome in terms of VAS score for pain at surgical site and thigh pain at 24 hrs, 48hrs and 1 week following TKR , between tourniquet pressures SBP+100mmHg,SBP+120mmHg and SBP+80mmHg.
It will also help to determine bloodless operative field at tibial and femoral cutting surface in terms of score(3 being best visibility and 2 being worst).
Secondary Objectives:
To evaluate the following and compare between the above mentioned groups- 1.Change in haemoglobin,48 hours after the procedure and estimated blood loss 2.Wound complications (wound ooze, infection), and skin complications of the operated limb (hematoma, blister or bleb), to be assessed 48hrs after surgery.
-
At 48 hours after TKR, level of total creatinine phosphokinase (CPK) concentration.
Knee ROM (Range of motion) before and 7 days post-surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 95.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with OA knee planned for primary TKR (any side)in AIIMS PATNA 2.Age group 18 and above 3.Consenting participants.
排除标准
- •1.Revision TKR.
- •2.Preop blood transfusion within 24hrs (PRBC only) 3.Evidence of recent Venous thromboembolism.
- •4.Contraindications for tourniquet use ( graft, peripheral vascular disease, calcified popliteals in xrays etc), cases where tourniquet is not used.
结局指标
主要结局
VAS score for pain
时间窗: 1.24hrs | 2.48hrs | 3.1 week
次要结局
- 1.Knee Range of motion and VAS score for pain will be assessed 7 days after surgery.(1.Knee Range of motion and VAS score for pain will be assessed 7 days after surgery.)
研究者
Dr Arijit Keshri
AIIMS PATNA