Supra Inguinal Fascia Iliaca Block as Rescue Analgesia Following Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 310
- 试验地点
- 2
- 主要终点
- Composite outcome
研究概览
简要总结
Hip replacement surgery is one of the most commonly performed surgical procedures in France, with approximately 150,000 procedures per year. Postoperative recovery has significantly improved in recent years, enabling faster rehabilitation.
Although generally considered moderately painful, hip replacement surgery can, in some difficult-to-predict cases, lead to severe postoperative pain, requiring high doses of morphine, which may cause side effects and delay recovery.
In other surgical procedures, regional anesthesia (nerve blocks) has been successfully used for pain relief. However, its effectiveness after hip replacement surgery has not yet been fully proven.
A recent regional anesthesia technique-the Supra-Inguinal Fascia Iliaca Block (SIFIB)-which numbs a significant portion of the nerves around the hip, has recently been developed.
When performed in all patients undergoing hip arthroplasty, the benefit of this technique could not be demonstrated. In addition, this technique may lead to transcient muscle blockade, wich also can delay recovery.
In order to limit the use of nerve blocks to painful patients, we designed this study where the nerve block is performed only in patients experiencing significant paint after surgery.
In conclusion, this study aims to assess the benefits of performing a rescue SIFIB in the recovery room for patients who experience significant postoperative pain after hip replacement surgery. The evaluation will focus on pain relief and ability to walk.
No new treatment is being tested. The technique uses a commonly administered local anesthetic to numb the nerves.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient scheduled for a primary total hip arthroplasty under general anesthesia,
- •written informed consent.
- •Non inclusion criteria:
- •contra indication to ropivacaine
- •vulnerable person
排除标准
- •per-operative complication making wheight-bearing and walking contra-indicated.
- •patient without significant pain post-operatively.
结局指标
主要结局
Composite outcome
时间窗: 2 hours post operatively
Composite outcome is validated if all of these 3 items are validated: * numerical pain rating scale (from 0 to 10) at rest is \< 4, * and intravenous morphine \< 0,1 mg/kg, * and first mobilization successful. First mobilization is validated if patient can stand up, walk 5 meters then sit down in a wheelchair.
次要结局
- Pain evaluation(6, 12 and 24 hours post operatively)
- Morphine consumption(24 hours post operatively)
- Length of hospital stay(An average of 2 to 3 days up to 1 week)
- Patient satisfaction(Day 1)
研究者
Abderrahmen BARGAOUI
Principal Investigator
Institut Mutualiste Montsouris