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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Oxford.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Natalia White, BA BMBCh, University of Oxford
ClinicalTrials.gov Identifier:
NCT01611064
First received: May 24, 2012
Last updated: June 2, 2012
Last verified: June 2012
  Purpose

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 Intervention
Hand Injuries/Disease Requiring Surgery to the Hand
Drug: Oxygen
Drug: Medical air

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Change in visual analogue scale pain score with time [ Time Frame: At 2 minute intervals for a total duration of 45 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart rate [ Time Frame: Every 6 minutes for a total duration of 45 minutes ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: Every 6 minutes for a total duration of 45 minutes ] [ Designated as safety issue: No ]
  • Oxygen saturations [ Time Frame: Every 6 minutes for a total duration of 45 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 62
Study Start Date: February 2012
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01611064

Contacts
Contact: Natalia White 07792 994968 natalia.white@hotmail.co.uk

Locations
United Kingdom
John Radcliffe Hospital Recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Natalia White, BA BMBCh    07792 994968    natalia.white@hotmail.co.uk   
Contact: Lucy Cogswell         
Sub-Investigator: Thomas Dobbs, BA BMBCh         
Sub-Investigator: Khurram Khan         
Sub-Investigator: George Murphy         
Sponsors and Collaborators
University of Oxford
Investigators
Principal Investigator: Natalia White, BA BMBCh Oxford University Hospitals Trust
  More Information

No publications provided

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
Study First Received: May 24, 2012
Last Updated: June 2, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Oxford:
Hand
Surgery
Tourniquet
Pain
Oxygen

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

ClinicalTrials.gov processed this record on July 29, 2014