Effectiveness of Bupivacaine in Pain Management following Breast Augmentation
| ISRCTN | ISRCTN81120207 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81120207 |
| Secondary identifying numbers | N0072186040 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 30/08/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
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
Contact information
Mr S Jayagopal
Scientific
Scientific
Countess of Chester Hospital NHS Foundation Trust
Liverpool Road
Chester
CH2 1UL
United Kingdom
| Phone | +44 01244 365000 |
|---|
Study information
| Study design | Randomised double blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Bupivacaine |
| Primary outcome measure | 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 study start date | 01/08/2006 |
| Completion date | 01/08/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Total 50; 25 in each group. |
| 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Countess of Chester Hospital NHS Foundation Trust
Chester
CH2 1UL
United Kingdom
CH2 1UL
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Countess of Chester NHS Foundation Trust
No information available
NHS R&D Support Funding
No information available
Results and Publications
| 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 |
