- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01611064
A Study Investigating Ways to Make Local Anaesthetic Hand Surgery Less Painful - Reducing Tourniquet Associated Pain (ReTAP)
May 27, 2015 updated by: Natalia White, BA BMBCh, University of Oxford
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).
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
- 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
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Oxford, United Kingdom, OX3 9DU
- John Radcliffe Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy
- More than 18 years of age
Exclusion Criteria:
- Diabetes
- 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
- Obesity
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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 Names:
|
Placebo Comparator: Air
Volunteer receives normal air at a rate of 10litres/minute by mask
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in visual analogue scale pain score with time
Time Frame: At 2 minute intervals for a total duration of 45 minutes
|
At 2 minute intervals for a total duration of 45 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Heart rate
Time Frame: Every 6 minutes for a total duration of 45 minutes
|
Every 6 minutes for a total duration of 45 minutes
|
Blood pressure
Time Frame: Every 6 minutes for a total duration of 45 minutes
|
Every 6 minutes for a total duration of 45 minutes
|
Oxygen saturations
Time Frame: Every 6 minutes for a total duration of 45 minutes
|
Every 6 minutes for a total duration of 45 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Natalia White, BA BMBCh, Oxford University Hospitals Trust
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
May 24, 2012
First Submitted That Met QC Criteria
May 30, 2012
First Posted (Estimate)
June 4, 2012
Study Record Updates
Last Update Posted (Estimate)
May 28, 2015
Last Update Submitted That Met QC Criteria
May 27, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ReTAP Study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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