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

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ClinicalTrials.gov Identifier: NCT01611064
Recruitment Status : Completed
First Posted : June 4, 2012
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment
Hand Injuries/Disease Requiring Surgery to the Hand Drug: Oxygen Drug: Medical air

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2012
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Oxygen
Volunteer receives oxygen at a rate of 10litres/minute by mask
Drug: 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
Other Name: O2
Placebo Comparator: Air
Volunteer receives normal air at a rate of 10litres/minute by mask
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
Other Names:
  • Room air
  • Piped air


Outcome Measures

Primary Outcome Measures :
  1. Change in visual analogue scale pain score with time [ Time Frame: At 2 minute intervals for a total duration of 45 minutes ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01611064


Locations
United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Sponsors and Collaborators
University of Oxford
Investigators
Principal Investigator: Natalia White, BA BMBCh Oxford University Hospitals Trust
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Natalia White, BA BMBCh, Senior House Officer in Plastic Surgery, Principle Investigator, University of Oxford
ClinicalTrials.gov Identifier: NCT01611064     History of Changes
Other Study ID Numbers: ReTAP Study
First Posted: June 4, 2012    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by Natalia White, BA BMBCh, University of Oxford:
Hand
Surgery
Tourniquet
Pain
Oxygen

Additional relevant MeSH terms:
Hand Injuries
Wounds and Injuries
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents