Hand Injuries/Disease Requiring Surgery to the HandReTAPNCT01611064
A Study Investigating Ways to Make Local Anaesthetic Hand Surgery Less Painful - Reducing Tourniquet Associated Pain
A study testing Oxygen and Medical air in people with Hand Injuries/Disease Requiring Surgery to the Hand, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hand Injuries/Disease Requiring Surgery to the Hand
- What is being tested?
- Oxygen and Medical air
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2012to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- More than 18 years of age
Who cannot join
- Diabetes
- Vascular disease
- Previous operations to arms
- Raynaud's disease
- Analgesia taken in last 24 hours
- Chronic pain
Show all 10Show fewer
- Hypertension
- Allergy to any substance used in the study
- Unable to give valid consent to participate
- Obesity
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Being tested
- Oxygen, Medical air
- Keywords
- Hand, Surgery, Tourniquet, Pain, Oxygen
- Medical subject headings
- Hand Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenDrug
Also called O2
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
Medical airDrug
Also called Room air, Piped 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
| Study group | Role | What they receive |
|---|---|---|
| Oxygen | Active comparator | Volunteer receives oxygen at a rate of 10litres/minute by mask Receives: Drug: Oxygen |
| Air | Placebo comparator | Volunteer receives normal air at a rate of 10litres/minute by mask Receives: Drug: Medical air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual analogue scale pain score with time
Measured: At 2 minute intervals for a total duration of 45 minutes
Secondary outcomes (3)
Heart rate
Measured: Every 6 minutes for a total duration of 45 minutes
Blood pressure
Measured: Every 6 minutes for a total duration of 45 minutes
Oxygen saturations
Measured: Every 6 minutes for a total duration of 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startFeb 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand Injuries/Disease Requiring Surgery to the HandStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalia White, BA BMBCh, University of Oxford
- Investigators
- Natalia White, BA BMBCh, Principal investigator, Oxford University Hospitals Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611064
- Sponsor's protocol ID
- ReTAP Study
- Acronym
- ReTAP
- Status last verified
- May 2015
- First submitted
- 24 May 2012
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25811584
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01611064
- Acronym / sponsor ID
- ReTAP / ReTAP Study
- Keywords
- Hand, Surgery, Tourniquet, Pain, Oxygen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 4 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygen | Active comparator | Drug: OxygenVolunteer receives oxygen at a rate of 10litres/minute by mask |
| Air | Placebo comparator | Drug: Medical airVolunteer receives normal air at a rate of 10litres/minute by mask |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy
- More than 18 years of age
Key exclusion criteria (10 listed)
- Diabetes
- Vascular disease
- Previous operations to arms
- Raynaud's disease
- Analgesia taken in last 24 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxygenAlso: O2Pure 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 | Drug | Oxygen |
| Medical airAlso: Room air, Piped airPure 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 | Drug | Air |
Primary outcome
Change in visual analogue scale pain score with time
Time frame: At 2 minute intervals for a total duration of 45 minutes
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Derived from this study: PubMed 25811584White 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalia White, BA BMBCh principal investigator
Oxford University Hospitals Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen and Medical air in people with Hand Injuries/Disease Requiring Surgery to the Hand, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in visual analogue scale pain score with time (time frame: At 2 minute intervals for a total duration of 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01611064, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.