Optimal Analgesia Following Metatarsal Surgery: A Prospective Randomised, Single-Blind Sham-Controlled Trial of Three Strategies
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Static pain score
研究概览
简要总结
A randomised trial comparing three analgesic strategies for patients undergoing forefoot surgery in a day-surgery setting.
详细描述
Forefoot surgery, including Scarf-Akin osteotomy surgery for bunion correction, is moderately painful orthopaedic surgery, commonly performed as a day-case procedure. Admission for opiate analgesia constitutes a failure of management and financial disadvantage to the healthcare organisation. The investigators seek to establish which technique will result in the best analgesia out of ankle block, metatarsal block, or a combination of the two. As analgesia constitutes part of a return to function, an additional aim is to determine whether either of these approaches will result in an objective functional benefit to the participants.
The trial seeks to recruit 23 patients into either of 3 groups: Ankle + sham metatarsal; sham Ankle + metatarsal; Ankle + Metatarsal.
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
- Single (Participant)
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
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or female, aged 18 years or above.
- •Diagnosed with 1st metatarsal pathology requiring surgical correction
- •Participant meets the criteria for operative management in our day-surgery unit
排除标准
- •Contraindication to general anaesthesia
- •Diabetic neuropathy affecting lower limbs
- •Peripheral neuropathy affecting lower limbs of any aetiology
- •Revision surgery
- •Lack of capacity to consent
结局指标
主要结局
Static pain score
时间窗: 6 hours post-operatively
Visual Analogue scores
次要结局
- Assessment of functional recovery(Day 7 post-operatively)
- Dynamic pain scores(Day 7 post-operatively)
- Static pain score(Day 7 post-operatively)
研究者
Dr James Stimpson
Consultant Anaesthetist
Queen Elizabeth Hospital NHS Foundation Trust