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

Hand Injuries/Disease Requiring Surgery to the Hand Clinical Trial

— ReTAP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01611064
• Other study ID #: ReTAP Study
• Status: Completed
• Phase: N/A
• First received: May 24, 2012
• Last updated: May 27, 2015
• Start date: February 2012
• Est. completion date: June 2012

Study information

• Verified date: May 2015
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hand Injuries
• Hand Injuries/Disease Requiring Surgery to the Hand

Intervention

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
• 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

Locations

Country	Name	City	State
United Kingdom	John Radcliffe Hospital	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in visual analogue scale pain score with time		At 2 minute intervals for a total duration of 45 minutes	No
Secondary	Heart rate		Every 6 minutes for a total duration of 45 minutes	No
Secondary	Blood pressure		Every 6 minutes for a total duration of 45 minutes	No
Secondary	Oxygen saturations		Every 6 minutes for a total duration of 45 minutes	No