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Completed

NCT Number: NCT01611064

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxygen

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

Other names: O2

Medical Air

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

Other names: Room air, Piped air

Primary outcomes

  1. Change in visual analogue scale pain score with time

    Time frame: At 2 minute intervals for a total duration of 45 minutes

Secondary outcomes

  1. Heart rate

    Time frame: Every 6 minutes for a total duration of 45 minutes

  2. Blood pressure

    Time frame: Every 6 minutes for a total duration of 45 minutes

  3. Oxygen saturations

    Time frame: Every 6 minutes for a total duration of 45 minutes

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study 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

Acronym: ReTAP

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 4, 2012
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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