Effectiveness of Bupivacaine in Pain Management following Breast Augmentation

ISRCTN	ISRCTN81120207
DOI	https://doi.org/10.1186/ISRCTN81120207
Protocol serial number	N0072186040
Sponsor	Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funders	Countess of Chester NHS Foundation Trust, NHS R&D Support Funding

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 S Jayagopal
Scientific

Countess of Chester Hospital NHS Foundation Trust
Liverpool Road
Chester
CH2 1UL
United Kingdom

Phone	+44 01244 365000

Primary study design	Interventional
Study design	Randomised double blind controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	1. Is bupivacaine better than placebo in reducing the post-operative pain? 2. Does bupivacaine used as supplement reduce the opiate dosage?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Signs and Symptoms: Pain
Intervention	A blinded member of the team will assess the pain at 2,4 and hours after the operation. Length of hospital stay is also recorded. The data analysis will take place at Countess of Chester Hospital (COCH). The research team at COCH will analyse the data using SPSS software.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Bupivacaine
Primary outcome measure(s)	Is bupivacaine superior than placebo in pain control following breast augmentation?
Key secondary outcome measure(s)	1. Does bupivacaine reduce opiate requirement? 2. Does it reduce hospital stay? 3. Does it reduce the incidence of opiate related adverse effects?
Completion date	01/08/2009

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	50
Key inclusion criteria	1. Patients undergoing breast augmentation 2. For correction of congenital anomaly or asymmetry. This group is usually young population, so usually not associated with co-morbid conditions which might complicate result.
Key exclusion criteria	1. Patients undergoing augmentation following mastectomy or as part of other reconstruction 2. Patients with multiple co-morbidity
Date of first enrolment	01/08/2006
Date of final enrolment	01/08/2009

Countess of Chester Hospital NHS Foundation Trust

Chester
CH2 1UL
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan