Condition category
Signs and Symptoms
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
30/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr S Jayagopal

ORCID ID

Contact details

Countess of Chester Hospital NHS Foundation Trust
Liverpool Road
Chester
CH2 1UL
United Kingdom
+44 01244 365000

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes