SUBpectoral Local anaesthetic Infusion following MastEctomy - version 1 (SUBLIME)

ISRCTN	ISRCTN46621916
DOI	https://doi.org/10.1186/ISRCTN46621916
EudraCT/CTIS number	2011-005775-16
Secondary identifying numbers	12964

Submission date: 05/09/2012
Registration date: 10/09/2012
Last edited: 29/05/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://www.cancerresearchuk.org/cancer-help/trials/a-trial-looking-extra-type-pain-control-after-surgery-remove-your-breast-sublime

Contact information

Ms Sarah Campbell
Scientific

Peninsula Clinical Trials Unit
Room N16
ITTC Building 1
Plymouth Science Park
Davy Road
Plymouth
PL6 8BX
United Kingdom

Phone	+44 (0)1752 430 392
Email	sarah.campbell@plymouth.ac.uk

Study information

Study design	Randomised interventional trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	A randomised, double blind, placebo-controlled trial of continuous subpectoral local anaesthetic infusion for pain and shoulder function following mastectomy
Study acronym	SUBLIME v1
Study objectives	The aim of the study is to establish whether the use of continuous local anaesthetic infusion in the sub-pectoral tissue plane can improve post-operative analgesia and quality of life for patients undergoing mastectomy with or without axillary surgery.
Ethics approval(s)	First MREC, 06/06/2012, ref: 12/SW/0149
Health condition(s) or problem(s) studied	Breast Cancer
Intervention	Participants will be randomised to receive 0.25% levobupivacaine or placebo (0.9% saline) by sub-pectoral infusion for 24 hours and will be followed up at 24 hours, 14 days and six months post-operatively.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Levobupivacaine
Primary outcome measure	Total morphine consumption, measured during the first 24 hours post-operatively
Secondary outcome measures	Total pain, measured using the Visual Analog Scale for Pain (VAS Pain) in the first 24 hours post-operatively
Overall study start date	15/10/2012
Completion date	14/08/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	UK Sample Size: 160
Key inclusion criteria	1. All women presenting for unilateral mastectomy surgery at the Royal Cornwall Hospitals NHS Trust and Royal Devon and Exeter NHS Foundation Trust 2. Female 3. Aged 18 years and over 4. Scheduled for unilateral mastectomy with or without axillary involvement
Key exclusion criteria	1. Inability to give informed consent 2. Primary reconstructive surgery 3. Hypotension, hypovolaemia or any form of shock 4. Known allergy or sensitivity to local anaesthetic agents, morphine, paracetamol or ondansetron 5. Pregnancy 6. Daily opioid analgesic use 7. Inability to understand or use a PCA device 8. Inability to understand or complete the visual analogue assessment tools 9. Concurrent participation in another interventional study that might conflict with this trial
Date of first enrolment	06/12/2012
Date of final enrolment	28/07/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

Royal Cornwall Hospitals NHS Trust

Truro
TR1 3LJ
United Kingdom

York Teaching Hospital NHS Foundation Trust

York
YO31 8HE
United Kingdom

Sponsor information

Royal Cornwall Hospitals NHS Trust (UK)
Hospital/treatment centre

Treliske
Truro
TR1 3LJ
England
United Kingdom

Website	http://www.rcht.nhs.uk/
"ROR"	https://ror.org/026xdcm93

Funders

Funder type

Government

National Institute for Health Research (ref: PB-PG-0610-22342)
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

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	To be confirmed at a later date
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	30/09/2014		Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

29/05/2019: Contact details updated.
28/05/2019: Internal review.
06/10/2016: The overall trial end date was changed from 14/10/2015 to 14/08/2016.
17/04/2014: The overall trial end date was changed from 14/10/2014 to 14/10/2015.