A Study Investigating Ways to Make Local Anaesthetic Hand Surgery Less Painful

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-06-30

Brief Summary

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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).

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Detailed Description

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* 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.

Conditions

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Hand Injuries/Disease Requiring Surgery to the Hand

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Oxygen

Volunteer receives oxygen at a rate of 10litres/minute by mask

Group Type ACTIVE_COMPARATOR

Oxygen

Intervention Type DRUG

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

Air

Volunteer receives normal air at a rate of 10litres/minute by mask

Group Type PLACEBO_COMPARATOR

Medical air

Intervention Type DRUG

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

Interventions

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Oxygen

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

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

Intervention Type DRUG

Other Intervention Names

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O2 Room air Piped air

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes