SUBpectoral Local anaesthetic Infusion following MastEctomy - version 1 (SUBLIME)
| ISRCTN | ISRCTN46621916 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46621916 |
| Clinical Trials Information System (CTIS) | 2011-005775-16 |
| Protocol serial number | 12964 |
| Sponsor | Royal Cornwall Hospitals NHS Trust (UK) |
| Funder | National Institute for Health Research (ref: PB-PG-0610-22342) |
- 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
Contact information
Ms Sarah Campbell
Scientific
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 |
|---|---|
| sarah.campbell@plymouth.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Levobupivacaine |
| Primary outcome measure(s) |
Total morphine consumption, measured during the first 24 hours post-operatively |
| Key secondary outcome measure(s) |
Total pain, measured using the Visual Analog Scale for Pain (VAS Pain) in the first 24 hours post-operatively |
| Completion date | 14/08/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centres
Royal Cornwall Hospitals NHS Trust
Truro
TR1 3LJ
United Kingdom
TR1 3LJ
United Kingdom
York Teaching Hospital NHS Foundation Trust
York
YO31 8HE
United Kingdom
YO31 8HE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
