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

ISRCTN	ISRCTN45404336
DOI	https://doi.org/10.1186/ISRCTN45404336
Secondary identifying numbers	N0021122446

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mr Christopher Khoo
Scientific

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

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	A double blind randomised controlled trial examining the efficacy of local anaesthesia in reducing post-operative pain when performing breast reductions
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	Patient's post-operative use of morphine using a PCA (patient controlled analgesia) device.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/05/2002
Completion date	01/05/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	Not provided at time of registration
Key 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.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/05/2002
Date of final enrolment	01/05/2004

Heatherwood and Wexham Park Hospitals NHS Trust

Slough
SL2 4HL
United Kingdom

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Hospital/treatment centre

Heatherwood and Wexham Park Hospitals NHS Trust (UK)

No information available

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

No publications found in PubMed, verifying study status with principal investigator.