Which is better: paravertebral (PV) or interpleural (IP) bupivacaine for breast surgery?

ISRCTN ISRCTN13771057
DOI https://doi.org/10.1186/ISRCTN13771057
Secondary identifying numbers N0072091240
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
04/02/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
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

Dr Sean Tighe
Scientific

Countess of Chester NHS Trust
Liverpool Road
Chester
CH3 1UL
United Kingdom

Phone +44 (0)1244 365000

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Breast
InterventionRandomisation 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Bupivacaine
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date01/04/2001
Completion date01/07/2003

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsProposed 40 patients - 20 in each group
Key inclusion criteriaAll patients having major breast surgery.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/04/2001
Date of final enrolment01/07/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Countess of Chester NHS Trust
Chester
CH3 1UL
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Countess of Chester Hospital NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan