Condition category
Cancer
Date applied
05/09/2012
Date assigned
10/09/2012
Last edited
01/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Ms Jane Vickery

ORCID ID

Contact details

Peninsula Clinical Trials Unit
Plymouth University
Plymouth Science Park
Davy Road
Plymouth
PL6 8BX
United Kingdom
-
jane.vickery@plymouth.ac.uk

Additional identifiers

EudraCT number

2011-005775-16

ClinicalTrials.gov number

Protocol/serial number

12964

Study information

Scientific title

A randomised, double blind, placebo-controlled trial of continuous subpectoral local anaesthetic infusion for pain and shoulder function following mastectomy

Acronym

SUBLIME v1

Study hypothesis

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

First MREC, 06/06/2012, ref: 12/SW/0149

Study design

Randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Levobupivacaine

Primary outcome measures

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 trial start date

15/10/2012

Overall trial end date

14/08/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

UK Sample Size: 160

Participant 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

Recruitment start date

06/12/2012

Recruitment end date

28/07/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Cornwall Hospitals NHS Trust
Truro
TR1 3LJ
United Kingdom

Trial participating centre

York Teaching Hospital NHS Foundation Trust
York
YO31 8HE
United Kingdom

Sponsor information

Organisation

Royal Cornwall Hospitals NHS Trust (UK)

Sponsor details

Treliske
Truro
TR1 3LJ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.rcht.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (ref: PB-PG-0610-22342)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25270861

Publication citations

  1. Protocol

    Langford R, Brown I, Vickery J, Mitchell K, Pritchard C, Creanor S, Study protocol for a double blind, randomised, placebo-controlled trial of continuous subpectoral local anaesthetic infusion for pain and shoulder function following mastectomy: SUB-pectoral Local anaesthetic Infusion following MastEctomy (SUBLIME) study., BMJ Open, 2014, 4, 9, e006318, doi: 10.1136/bmjopen-2014-006318.

Additional files

Editorial Notes

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.