Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0072186040
Study information
Scientific title
Acronym
Study hypothesis
1. Is bupivacaine better than placebo in reducing the post-operative pain?
2. Does bupivacaine used as supplement reduce the opiate dosage?
Ethics approval
Not provided at time of registration
Study design
Randomised double blind controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Bupivacaine
Primary outcome measures
Is bupivacaine superior than placebo in pain control following breast augmentation?
Secondary outcome measures
1. Does bupivacaine reduce opiate requirement?
2. Does it reduce hospital stay?
3. Does it reduce the incidence of opiate related adverse effects?
Overall trial start date
01/08/2006
Overall trial end date
01/08/2009
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Total 50; 25 in each group.
Participant exclusion criteria
1. Patients undergoing augmentation following mastectomy or as part of other reconstruction
2. Patients with multiple co-morbidity
Recruitment start date
01/08/2006
Recruitment end date
01/08/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Countess of Chester Hospital NHS Foundation Trust
Chester
CH2 1UL
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 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
Funders
Funder type
Government
Funder name
Countess of Chester NHS Foundation Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
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