A Randomised Controlled Trial to Investigate Whether Oxygen Supplementation Can Extend the Time Tolerated or Reduce the Pain Associated With an Upper Limb Tourniquet for Hand Surgery Under Local Anaesthetic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in visual analogue scale pain score with time
研究概览
简要总结
Hand surgery requires a reduced blood flow to the hand during the operation, which is achieved using a tourniquet (tightly inflated circumferential cuff) around the upper arm. However this tourniquet is painful. This study investigates whether breathing oxygen can reduce the pain associated with the tourniquet to both improve patient experience and potentially to allow longer operations to be completed under a local anaesthetic (rather than a general anaesthetic, where the patient is put to sleep, which is more costly, time consuming and risky for the patient).
详细描述
- This study is a randomised controlled trial of healthy volunteers (for example medical students, nurses and doctors).
- Each volunteer is randomised to receive either oxygen or normal air through a mask whilst wearing an inflated upper arm tourniquet and rating their pain on a scale. The equipment set-up is identical for each volunteer, with the tourniquet inflated to a pressure of 250mmHg in every person.
- Within each arm of the study, volunteers are again randomised to wear the tourniquet on either their dominant or non-dominant arm.
- The study is double-blind (the volunteer and the investigator running the test are unaware of whether oxygen or air is being received) to avoid bias.
- The volunteer can ask for the tourniquet to be removed at any time and will wear the tourniquet for a maximum of 30 minutes.
- The pain ratings and also heart rate and blood pressure are then analysed to identify whether the volunteers receiving oxygen experienced less pain or were able to tolerate the tourniquet for longer than those receiving air.
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
- Triple (Participant, Investigator, 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
- 是
入选标准
- •More than 18 years of age
排除标准
- •Vascular disease
- •Previous operations to arms
- •Raynaud's disease
- •Analgesia taken in last 24 hours
- •Chronic pain
- •Hypertension
- •Allergy to any substance used in the study
- •Unable to give valid consent to participate
研究组 & 干预措施
Oxygen
Volunteer receives oxygen at a rate of 10litres/minute by mask
干预措施: Oxygen (Drug)
Air
Volunteer receives normal air at a rate of 10litres/minute by mask
干预措施: Medical air (Drug)
结局指标
主要结局
Change in visual analogue scale pain score with time
时间窗: At 2 minute intervals for a total duration of 45 minutes
次要结局
- Blood pressure(Every 6 minutes for a total duration of 45 minutes)
- Heart rate(Every 6 minutes for a total duration of 45 minutes)
- Oxygen saturations(Every 6 minutes for a total duration of 45 minutes)
研究者
Natalia White, BA BMBCh
Senior House Officer in Plastic Surgery, Principle Investigator
University of Oxford