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A Study Investigating Ways to Make Local Anaesthetic Hand Surgery Less Painful - Reducing Tourniquet Associated Pain

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01611064
Acronym
ReTAP
Enrollment
50
Registered
2012-06-04
Start date
2012-02-29
Completion date
2012-06-30
Last updated
2015-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand Injuries/Disease Requiring Surgery to the Hand

Keywords

Hand, Surgery, Tourniquet, Pain, Oxygen

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.

Interventions

DRUGOxygen

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

DRUGMedical 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

Sponsors

University of Oxford
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Change in visual analogue scale pain score with timeAt 2 minute intervals for a total duration of 45 minutes

Secondary

MeasureTime frame
Heart rateEvery 6 minutes for a total duration of 45 minutes
Blood pressureEvery 6 minutes for a total duration of 45 minutes
Oxygen saturationsEvery 6 minutes for a total duration of 45 minutes

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026