Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
20/07/2012
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 S Krone

ORCID ID

Contact details

The Queen Victoria Hospital NHS Trust
Holtye Road
East Grinstead
RH19 3DZ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0190161953

Study information

Scientific title

Acronym

Study hypothesis

To evaluate the analgesic effect of local anaesthetic in the retro-mammary space under ultrasound guidance.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Condition

Surgery: Breast

Intervention

Ultrasound guided retro-mammary blocks vs normal practice

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

The total analgesic requirements during the first 24 hours post-operatively

Secondary outcome measures

Not provided at time of registration

Overall trial start date

30/07/2005

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

40 cases (90% power, p= 0.05) with following criteria:
1. Male and female patients having unilateral or bilateral breast surgery not involving the axilla
2. Age 16-70

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. No consent
2. Allergy to local anaesthetic
3. Clotting disorder

Recruitment start date

30/07/2005

Recruitment end date

31/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Queen Victoria Hospital NHS Trust
East Grinstead
RH19 3DZ
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

Queen Victoria Hospital NHS Trust (UK), NHS R&D Support Funding

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

Publication citations

Additional files

Editorial Notes