Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
04/02/2014
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

Dr Sean Tighe

ORCID ID

Contact details

Countess of Chester NHS Trust
Liverpool Road
Chester
CH3 1UL
United Kingdom
+44 (0)1244 365000

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0072091240

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Surgery: Breast

Intervention

Randomisation to two groups, standardised general anaesthetic, IP or PV block, recovery, test for failure, observed for pain, nausea and vomiting (N&V), patient-controlled analgesia (PCA) morphine consumption.

Intervention type

Drug

Phase

Not Specified

Drug names

Bupivacaine

Primary outcome measures

1. Visual Analogue Pain Scores at rest and on movement
2. Nausea scale and vomiting episodes
3. Morphine and other analgesic consumption
4. Time to morphine demand
5. Hospital stay

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2001

Overall trial end date

01/07/2003

Reason abandoned

Eligibility

Participant inclusion criteria

All patients having major breast surgery.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Proposed 40 patients - 20 in each group

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/04/2001

Recruitment end date

01/07/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Countess of Chester NHS Trust
Chester
CH3 1UL
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Countess of Chester Hospital NHS Trust (UK)

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