Clinical trial NCT01611064: A Study Investigating Ways to Make Local Anaesthetic Hand Surgery Less Painful - Reducing Tourniquet Associated Pain
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Injuries/Disease Requiring Surgery to the Hand
Keywords: Hand
Surgery
Tourniquet
Pain
Oxygen
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2012-06-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
measure: Change in visual analogue scale pain score with time
timeFrame: At 2 minute intervals for a total duration of 45 minutes
Secondary outcomes:
measure: Heart rate
timeFrame: Every 6 minutes for a total duration of 45 minutes
measure: Blood pressure
timeFrame: Every 6 minutes for a total duration of 45 minutes
measure: Oxygen saturations
timeFrame: Every 6 minutes for a total duration of 45 minutes
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: Oxford University Hospitals Trust
name: Natalia White, BA BMBCh
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.