Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
08/09/2015
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

Mr Christopher Khoo

ORCID ID

Contact details

Heatherwood and Wexham Park Hospitals NHS Trust
Department of Plastic Surgery
Wexham Park Hospital
Wexham Street
Slough
SL2 4HL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0021122446

Study information

Scientific title

A double blind randomised controlled trial examining the efficacy of local anaesthesia in reducing post-operative pain when performing breast reductions

Acronym

Study hypothesis

The aim is to establish whether infiltrating the breast with a very low concentration of local anaesthetic solution reduces post-operative pain following breast reducing surgery.

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

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

Signs and Symptoms: Pain

Intervention

Following induction of anaesthesia, 500 ml of a solution of adrenaline in normal saline (control) or bupivicaine plus adrenaline in normal saline (experimental) will be infiltrated into each breast. Both the patient and the surgeon will be blinded to the patient's trial group allocation.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Patient's post-operative use of morphine using a PCA (patient controlled analgesia) device.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/2002

Overall trial end date

01/05/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Women aged 18 and over attending the Plastic Surgery Department at Wexham Park Hospital for breast reduction. Patient's with a history of substance abuse or who have a known allergy to the agents used will be excluded.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/05/2002

Recruitment end date

01/05/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Heatherwood and Wexham Park Hospitals NHS Trust
Slough
SL2 4HL
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Heatherwood and Wexham Park 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

Publication citations

Additional files

Editorial Notes