A Study Investigating Ways to Make Local Anaesthetic Hand Surgery Less Painful - Reducing Tourniquet Associated Pain (ReTAP)
Primary Purpose
Hand Injuries/Disease Requiring Surgery to the Hand
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Oxygen
Medical air
Sponsored by
About this trial
This is an interventional treatment trial for Hand Injuries/Disease Requiring Surgery to the Hand focused on measuring Hand, Surgery, Tourniquet, Pain, Oxygen
Eligibility Criteria
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
Sites / Locations
- John Radcliffe Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Oxygen
Air
Arm Description
Volunteer receives oxygen at a rate of 10litres/minute by mask
Volunteer receives normal air at a rate of 10litres/minute by mask
Outcomes
Primary Outcome Measures
Change in visual analogue scale pain score with time
Secondary Outcome Measures
Heart rate
Blood pressure
Oxygen saturations
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01611064
Brief Title
A Study Investigating Ways to Make Local Anaesthetic Hand Surgery Less Painful - Reducing Tourniquet Associated Pain
Acronym
ReTAP
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 Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oxford
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Injuries/Disease Requiring Surgery to the Hand
Keywords
Hand, Surgery, Tourniquet, Pain, Oxygen
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxygen
Arm Type
Active Comparator
Arm Description
Volunteer receives oxygen at a rate of 10litres/minute by mask
Arm Title
Air
Arm Type
Placebo Comparator
Arm Description
Volunteer receives normal air at a rate of 10litres/minute by mask
Intervention Type
Drug
Intervention Name(s)
Oxygen
Other Intervention Name(s)
O2
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Medical air
Other Intervention Name(s)
Room air, Piped air
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in visual analogue scale pain score with time
Time Frame
At 2 minute intervals for a total duration of 45 minutes
Secondary Outcome Measure Information:
Title
Heart rate
Time Frame
Every 6 minutes for a total duration of 45 minutes
Title
Blood pressure
Time Frame
Every 6 minutes for a total duration of 45 minutes
Title
Oxygen saturations
Time Frame
Every 6 minutes for a total duration of 45 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalia White, BA BMBCh
Organizational Affiliation
Oxford University Hospitals Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
John Radcliffe Hospital
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
25811584
Citation
White N, Dobbs TD, Murphy GRF, Khan K, Batt JP, Cogswell LK. Oxygen reduces tourniquet-associated pain: a double-blind, randomized, controlled trial for application in hand surgery. Plast Reconstr Surg. 2015 Apr;135(4):721e-730e. doi: 10.1097/PRS.0000000000001028.
Results Reference
derived
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A Study Investigating Ways to Make Local Anaesthetic Hand Surgery Less Painful - Reducing Tourniquet Associated Pain
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