Comparison of Postoperative Pain in Primary Cemented Total Knee Arthroplasty With or Without Drain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Preoperative baseline pain and postoperative pain at discharge
研究概览
简要总结
The use of closed aspirative surgical drainage presents a truly questionable role in the field of orthopedic surgery.
The pathophysiological mechanisms on which it acts have been widely theorized, as well as the disadvantages that could be associated, both at a biological and socio-sanitary level, so that clinical guidelines opt to leave the decision to the surgeon's discretion.
Although its application and postoperative complications in knee arthroplasty are widely documented, the results are inconclusive and the scientific community does not seem to reach a consensus.
The main debate centers on bleeding during the immediate postoperative period, a classic complication of these interventions, but which seems to be being avoided with the introduction of new techniques and drugs, mainly the use of tranexamic acid.
However, a fundamental element of the postoperative period of these interventions that all the research seems to omit is pain in the postoperative period, which is key, as the pain of gonarthrosis is the main indication for the intervention.
It is because of this lack in the essential knowledge of this intervention that we propose the following hypothesis: the use of drainage in knee arthroplasty does not reduce pain during the early postoperative period.
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
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 60 years of age
- •Candidates for hybrid total knee arthroplasty with preservation of the posterior cruciate ligament
排除标准
- •Patients with previous ipsilateral or contralateral knee surgery (contralateral knee arthroplasty, osteotomized, previous cruciate ligament or meniscal repair included)
- •History of rheumatologic diseases
- •History of articular infection
研究组 & 干预措施
DRAINAGE GROUP (A)
Patients in group A will have a Redon drain placed at the end of the procedure. Both groups of patients will be explained early active flexion-extension exercises to initiate mobilization and multimodal analgesia will be provided. Patients in group A will receive perioperative care adapted to the drainage. All patients will have their baseline pain measured preoperatively and postoperatively using an analog rating scale. Patients will be checked if they require morphine rescue analgesia during their hospital stay. Postoperative pain assessment will be performed at discharge.
干预措施: Redon drain (Procedure)
NO DRAINAGE GROUP (B)
Patients in group B will not have a Redon drain placed at the end of the procedure.
Both groups of patients will be explained early active flexion-extension exercises to initiate mobilization and multimodal analgesia will be provided. All patients will have their baseline pain measured preoperatively and postoperatively using an analog rating scale. Patients will be checked if they require morphine rescue analgesia during their hospital stay. Postoperative pain assessment will be performed at discharge.
结局指标
主要结局
Preoperative baseline pain and postoperative pain at discharge
时间窗: Preoperative baseline pain (Day 0) and postoperative pain at discharge (Day 2)
Preoperative baseline pain and postoperative pain at discharge, both assessed using an Analog Rating Scale (scale 0-10)
次要结局
- Body Mass Index(BMI measured in Day 0 (at the time of admision in hospital))
研究者
Jesús Castellano Curado
Principal Investigator
Hospital Universitario Reina Sofia de Cordoba