Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
15/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

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

  1. 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.

Additional files

Editorial Notes