Adductor Under Sartorial Canal Catheter (KTT) Versus Femoral Catheter (KTF) in a Quick Rehabilitation Process After Total Knee Replacement: A Controlled, Randomized Study (KTSS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- International clinical score Daniels and Worthingham
研究概览
简要总结
The main objective of this study is to show that postoperative Total Knee Replacement (TKR), an analgesic perineural catheter in position under sartorial (KTSS) best preserves motor quadriceps femoral perineural catheter that (KTF) infused with even low doses of local anesthetics, this motor being evaluated by a semi quantitative simple clinical test locking of the knee feasible at the bedside.
Patients will be randomized in two arms:
- catheter in position under sartorial (experimental group)
- femoral catheter (control group)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major Patient (≥ 18 years)
- •Before tricompartmental benefit from knee replacement (TKR) unilateral,
- •TKR programmed on one of the first three days of the week (Monday to Wednesday)
- •Physical status score I-III,
- •Non septic programmed surgery under general anesthesia
- •Able to understand the protocol
- •Written informed consent
- •Social Insured
- •Opportunity to be followed under the Protocol
排除标准
- •Age ≥ 85 years
- •Obesity (BMI ≥ 35)
- •Revision TKR,
- •Patients not cooperating or not including the French,
- •Difficulties in understanding and evaluating the score pain (VAS),
- •Preoperative cognitive dysfunction making unreliable interrogation
- •Patient unable to read and / or write (literacy, ...)
- •Known bleeding disorders,
- •Vascular surgery for femoral vessels on the operated side,
- •Neuropathy of the lower limb,
- •Localized infection at the puncture catheters,
- •Known allergy to ropivacaine,
- •Renal and / or severe hepatic impairment,
- •Taking opioids for more than a month before surgery,
- •Intolerance to morphine,
- •Rheumatic inflammatory disease,
- •Patients receiving immunosuppressive therapy or long-term corticosteroid
- •Allergy or against-indications to standard treatments administered intraoperative and postoperative
- •Flexion deformity> 10 ° or valgus deformity with significant
- •Refused to participate
- •Patient trusteeship, guardianship, deprived of liberty
- •Women premenopausal who become pregnant
研究组 & 干预措施
under sartorial catheter
catheter under sartorial
干预措施: under sartorial catheter (Device)
femoral catheter
femoral catheter
干预措施: femoral catheter (Device)
结局指标
主要结局
International clinical score Daniels and Worthingham
时间窗: 2 day after surgery (total knee replacement)
This score measures the driving force of the quadriceps (scale M0: no contraction in M5: normal force)
次要结局
未报告次要终点