NCT01611064

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2012

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2012

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

4 months

First QC Date

May 24, 2012

Last Update Submit

May 27, 2015

Conditions

Hand Injuries/Disease Requiring Surgery to the Hand

Keywords

HandSurgeryTourniquetPainOxygen

Outcome Measures

Primary Outcomes (1)

  • Change in visual analogue scale pain score with time

    At 2 minute intervals for a total duration of 45 minutes

Secondary Outcomes (3)

  • Heart rate

    Every 6 minutes for a total duration of 45 minutes

  • Blood pressure

    Every 6 minutes for a total duration of 45 minutes

  • Oxygen saturations

    Every 6 minutes for a total duration of 45 minutes

Study Arms (2)

Oxygen

ACTIVE COMPARATOR

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

Drug: Oxygen

Air

PLACEBO COMPARATOR

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

Drug: Medical air

Interventions

OxygenDRUG

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

Also known as: O2
Oxygen
Medical airDRUG

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

Also known as: Room air, Piped air
Air

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy
  • More than 18 years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (1)

  • White N, Dobbs TD, Murphy GRF, Khan K, Batt JP, Cogswell LK. Oxygen reduces tourniquet-associated pain: a double-blind, randomized, controlled trial for application in hand surgery. Plast Reconstr Surg. 2015 Apr;135(4):721e-730e. doi: 10.1097/PRS.0000000000001028.

    PMID: 25811584DERIVED

MeSH Terms

Conditions

Hand InjuriesPain

Interventions

OxygenAir

Condition Hierarchy (Ancestors)

Wounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGasesAtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public Health

Study Officials

  • Natalia White, BA BMBCh

    Oxford University Hospitals Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior House Officer in Plastic Surgery, Principle Investigator

Study Record Dates

First Submitted

May 24, 2012

First Posted

June 4, 2012

Study Start

February 1, 2012

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

GB(1)