A modified technique of intravenous regional anaesthesia (IVRA) using upper arm double tourniquet with temporary mid forearm tourniquet - does it improve regional anaesthesia and postoperative analgesia for hand surgery?

ISRCTN	ISRCTN96783602
DOI	https://doi.org/10.1186/ISRCTN96783602
Secondary identifying numbers	N0050124903

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 15/08/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Stephen Fletcher
Scientific

Anaesthesia
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Phone	+44 (0)1274 364065
Email	sjfletcher@doctors.org.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	Does the use of a temporary mid forearm tourniquet during IVRA improve anaesthesia for hand surgery?
Ethics approval(s)	Added 04 September 2009: Ethics approval was received from the local medical ethics committee before trial recruitment began.
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	20/05/2003
Completion date	31/10/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	Added 04 September 2009: 50
Key inclusion criteria	Adult patients presenting for elective minor hand surgery, under IVRA, at St Luke's Hospital.
Key exclusion criteria	Added 04 September 2009: patient refusal.
Date of first enrolment	20/05/2003
Date of final enrolment	31/10/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Anaesthesia

Bradford
BD9 6RJ
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Bradford Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2011		Yes	No