Hand Injuries/Disease Requiring Surgery to the Hand Clinical Trial
Official title:
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
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).
- 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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment