A Study Investigating Ways to Make Local Anaesthetic Hand Surgery Less Painful - Reducing Tourniquet Associated Pain (ReTAP)
|ClinicalTrials.gov Identifier: NCT01611064|
Recruitment Status : Completed
First Posted : June 4, 2012
Last Update Posted : May 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hand Injuries/Disease Requiring Surgery to the Hand||Drug: Oxygen Drug: Medical air||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
Active Comparator: Oxygen
Volunteer receives oxygen at a rate of 10litres/minute by mask
Pure oxygen delivered by simple adult oxygen mask at rate of 10 litres/minute. Commencing 3 minutes prior to tourniquet inflation and administered for a maximum of 45 minutes
Other Name: O2
Placebo Comparator: Air
Volunteer receives normal air at a rate of 10litres/minute by mask
Drug: Medical air
Pure medical air (21% oxygen content) delivered by simple adult oxygen mask at rate of 10 litres/minute. Commencing 3 minutes prior to tourniquet inflation and administered for a maximum of 45 minutes
- Change in visual analogue scale pain score with time [ Time Frame: At 2 minute intervals for a total duration of 45 minutes ]
- Heart rate [ Time Frame: Every 6 minutes for a total duration of 45 minutes ]
- Blood pressure [ Time Frame: Every 6 minutes for a total duration of 45 minutes ]
- Oxygen saturations [ Time Frame: Every 6 minutes for a total duration of 45 minutes ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01611064
|John Radcliffe Hospital|
|Oxford, United Kingdom, OX3 9DU|
|Principal Investigator:||Natalia White, BA BMBCh||Oxford University Hospitals Trust|