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

ISRCTN	ISRCTN13771057
DOI	https://doi.org/10.1186/ISRCTN13771057
Protocol serial number	N0072091240
Sponsor	Department of Health (UK)
Funder	Countess of Chester Hospital NHS Trust (UK)

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

Dr Sean Tighe
Scientific

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

Phone	+44 (0)1244 365000

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Bupivacaine
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/07/2003

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	40
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

Countess of Chester NHS Trust

Chester
CH3 1UL
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan