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
Scientific
Countess of Chester NHS Trust
Liverpool Road
Chester
CH3 1UL
United Kingdom
| Phone | +44 (0)1244 365000 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Bupivacaine |
| Primary outcome measure | 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 study start date | 01/04/2001 |
| Completion date | 01/07/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Proposed 40 patients - 20 in each group |
| Key inclusion criteria | All patients having major breast surgery. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/04/2001 |
| Date of final enrolment | 01/07/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Countess of Chester NHS Trust
Chester
CH3 1UL
United Kingdom
CH3 1UL
United Kingdom
Sponsor information
Department of Health (UK)
Government
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
