Contact information
Type
Scientific
Primary contact
Dr Stephen Fletcher
ORCID ID
Contact details
Anaesthesia
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
+44 (0)1274 364065
sjfletcher@doctors.org.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0050124903
Study information
Scientific title
Acronym
Study hypothesis
Does the use of a temporary mid forearm tourniquet during IVRA improve anaesthesia for hand surgery?
Ethics approval
Added 04 September 2009: Ethics approval was received from the local medical ethics committee before trial recruitment began.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Surgery: Hand
Intervention
Patients having elective hand surgery, under IVRA, will be randomised into two groups. One group will have the standard technique of IVRA and the other group will have a modified technique whereby an additional forearm tourniquet is also applied. Anaesthesia of the hand will be assessed using forceps pinch and patient assessment of comfort during the operation. Postoperative analgesia will be measured by patient assessment of comfort thirty minutes after the end of the operation. The two techniques will be compared to see if the modified technique produces quicker onset, better anaesthesia and improved postoperative analgesia.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
1. Speed of onset of anaesthesia
2. Assessment of anaesthesia over area to be incised
3. Total volume of local anaesthetic (LA) infiltrated by surgeon during procedure
4. Patient comfort during procedure and thirty minutes postoperatively (using Visual Analogue Scores)
Secondary outcome measures
Not provided at time of registration
Overall trial start date
20/05/2003
Overall trial end date
31/10/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Adult patients presenting for elective minor hand surgery, under IVRA, at St Luke's Hospital.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Added 04 September 2009: 50
Participant exclusion criteria
Added 04 September 2009: patient refusal.
Recruitment start date
20/05/2003
Recruitment end date
31/10/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Anaesthesia
Bradford
BD9 6RJ
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Bradford Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21088591
Publication citations
-
Results
Fletcher SJ, Hulgur MD, Varma S, Lawrence E, Boome RS, Oswal S, Use of a temporary forearm tourniquet for intravenous regional anaesthesia: a randomised controlled trial., Eur J Anaesthesiol, 2011, 28, 2, 133-136, doi: 10.1097/EJA.0b013e3283410131.