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
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