Efficacy of ultrasound guided retro-mammary blocks for post-operative pain control in patients undergoing breast surgery

ISRCTN	ISRCTN77346567
DOI	https://doi.org/10.1186/ISRCTN77346567
Protocol serial number	N0190161953
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funder	Queen Victoria Hospital NHS Trust (UK), NHS R&D Support Funding

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 S Krone
Scientific

The Queen Victoria Hospital NHS Trust
Holtye Road
East Grinstead
RH19 3DZ
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To evaluate the analgesic effect of local anaesthetic in the retro-mammary space under ultrasound guidance.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Breast
Intervention	Ultrasound guided retro-mammary blocks vs normal practice
Intervention type	Procedure/Surgery
Primary outcome measure(s)	The total analgesic requirements during the first 24 hours post-operatively
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	40
Key inclusion criteria	40 cases (90% power, p= 0.05) with following criteria: 1. Male and female patients having unilateral or bilateral breast surgery not involving the axilla 2. Age 16-70
Key exclusion criteria	1. No consent 2. Allergy to local anaesthetic 3. Clotting disorder
Date of first enrolment	30/07/2005
Date of final enrolment	31/12/2006

The Queen Victoria Hospital NHS Trust

East Grinstead
RH19 3DZ
United Kingdom

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