| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN81120207 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0072186040 |
| Public title | Effectiveness of Bupivacaine in Pain Management following Breast Augmentation |
| Scientific title |
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| Acronym | N/A |
| Disease/condition/study domain | Signs and Symptoms: Pain |
| Study hypothesis | 1. Is bupivacaine better than placebo in reducing the post-operative pain?
2. Does bupivacaine used as supplement reduce the opiate dosage? |
| Design/methodology | Randomised double blind controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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. |
| Participants - exclusion criteria | 1. Patients undergoing augmentation following mastectomy or as part of other reconstruction
2. Patients with multiple co-morbidity |
| Patient information material |
|
| Anticipated start date | 01/08/2006 |
| Anticipated end date | 01/08/2009 |
| Status of trial | Ongoing |
| Target number of participants | Total 50; 25 in each group. |
| Interventions | 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. |
| Primary outcome measure(s) | Is bupivacaine superior than placebo in pain control following breast augmentation? |
| 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? |
| Sources of funding | Countess of Chester NHS Foundation Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Mr S Jayagopal |
| Contact details | Countess of Chester Hospital NHS Foundation Trust
Liverpool Road
Chester
United Kingdom
CH2 1UL |
| Contact telephone | +44 01244 365000 |
| Contact fax | +44 01244 366277 |
| Contact email | sathish_jayagopal@yahoo@co.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN81120207 |
| Date last extracted from ISRCTN register | 17/04/2008 |
