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
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