Non-interventional Study Evaluating the Management of Pain Using a Technique Developed and Commonly Used by the Center, in Patients Who Underwent Arthroscopic Surgery of the Shoulder in the Outpatient Setting.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Average of pain
研究概览
简要总结
Shoulder surgery is performed usually under interscalene block considered as a gold standard. This anesthesia is well suited for hospitalized patients but not for outpatients. The Orthopedic Surgery Department of Clinique Chénieux has been operating patients requiring arthroscopic shoulder surgery with a short interscalene block relayed by a long suprascapular block. The main objective is to evaluate the effectiveness of this method by measuring the average pain over 3 days after the operation.
详细描述
The surgery of the shoulder is usually performed under interscalene block (ISB), considered as a gold standard. This anesthesia is well suited for hospitalized patients but not for outpatients. Indeed, the ISB entails, in addition to a sensory block, a motor block often useless and important since it extends beyond the shoulder to the entire upper limb. It can also be a source of anxiety and cause the risk of compression in the limb operated because of the extended sensorimotor block. It is also responsible for a painful bounce almost constant with sometimes the very rapid installation of intense pain when the effect of the sensory block disappears. This pain can be difficult to relieve despite frequent use of opioids.
The Orthopedic and Traumatologic Surgery Department of the Clinique Chénieux has been operating patients requiring arthroscopic surgery of the shoulder according to the following technique. It involves the establishment of a short ISB (between 2h and 4h) relayed by a supra-scapular block (SSB) long (72h) through the placement of a perineural catheter thus allowing a continuous diffusion of Naropein® by an elastomeric pump. The same day or the day after the operation, the patients return to their home and are followed by nurses.
The objective of this technique is to better manage postoperative pain, thus allowing the management of patients in outpatient surgery. A prospective non-interventional study will make it possible, in a context of common practice, to obtain data on the management of pain in operated patients and then to consider a generalization of this practice to other centers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men, women between 18 and 70 years
- •Patient in need of acromioplasty or rotator cuff surgery (ruptured cuff or calcification of the cuff) or reinsertion of the glenoid bead (Bankart intervention)
- •Patient with an American Society of Anesthesiologists score (ASA) of 1 or 2
排除标准
- •Patient needing shoulder surgery for other indications and open surgery
- •Patient with cognitive impairment or dementia symptoms
- •Patient with a BMI ≥ 35 without systemic morbidity requiring hospitalization
- •Contraindication to the drugs used in the study (hypersensitivity to ropivacaine or other amide-bonded local anesthetics)
- •Pregnant or lactating patient
- •Patient with severe hepatic impairment
- •Class III antiarrhythmic patient
结局指标
主要结局
Average of pain
时间窗: Day 3
core of average pain at D3 by a numeric pain scale (NPS) \<4/10
次要结局
- Number of postoperative complications(Month 3)
- Number of readmissions(Day 7)
- Number of painful peaks(Day 0)
- Analgesics consummation(Day 1, Day 2, Day 3, Day 4 and Day 7)
- Cartilaginous Toxicology(Month 6 and Month 12)
- Score of Pain(Day 4, Day 7, Day 15 and Day 30)
- Satisfied patient rate(Day 30)
