A randomised double-blind placebo-controlled trial of Sub-Pectoral catheter bupivacaine Infusion for post-mastectomy pain
| ISRCTN | ISRCTN71076101 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71076101 |
| Secondary identifying numbers | N/A |
- Submission date
- 01/11/2007
- Registration date
- 03/04/2008
- Last edited
- 18/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
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
Contact information
Dr Gail Gillespie
Scientific
Scientific
Royal Cornwall Hospital Trust
Treliske
Truro, Cornwall
TR1 3LJ
United Kingdom
Study information
| Study design | A prospective, single-centre, double blind randomised placebo-controlled study |
|---|---|
| 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 below to request a patient information sheet |
| Scientific title | |
| Study acronym | SPI-Mas |
| Study objectives | The primary common complications of mastectomy with axillary node clearance are post-operative pain and slow recovery of shoulder function. Historically, mastectomy patients are managed on the wards with systemic opiates, either by intramuscular injection or using a Patient Controlled Analgesia (PCA) device. Problems commonly associated with this technique are inadequate pain control, post-operative nausea and vomiting, poor recovery of shoulder function and chronic pain. We ask the question: can post-operative analgesia be improved in this patient group by the use of local anaesthetic infusion via a sub pectoral catheter? This prospective, randomised double blind placebo-controlled study of patients undergoing mastectomy plus axillary sampling or clearance for breast cancer aims to investigate whether this technique confers any advantages over current practice. |
| Ethics approval(s) | Ethics approval will be submitted from the Cornwall NHS Hospitals Local Research and Ethics Committee. Pending as of 06/11/2007. |
| Health condition(s) or problem(s) studied | Post-mastectomy pain |
| Intervention | Local anaesthetic bupivacaine infusion (initial bolus of 20 ml of 0.5% sterile bupivacaine) via a sub-pectoral catheter inserted intra-operatively versus saline control (initial bolus of 20 ml sterile saline 0.9%). Thereafter continuous drug infusion will be 270 ml of either 0.25% bupivacaine or of 0.9% saline via an elastomeric infusion device delivering 5 ml/hr over 48 hours. All study arms have same duration. Initial phase of study is for the first 10 days following surgery, the second phase is the follow-up at 6 and 12 months. Total duration will therefore be 12 months. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Bupivacaine |
| Primary outcome measure | Post-operative analgesia as assessed by: 1. Total morphine requirements at 24 and 48 hours 2. Pain scores at rest on first wakening using a Verbal Rating Scale 3. Pain scores at rest and on movement using a Visual Analogue Scale at 24 and 48 hours 4. Time from end of surgery to first analgesia 5. Subsequent oral analgesia (oromorph) requirements |
| Secondary outcome measures | 1. Pain scores at rest and on movement using a Visual Analogue Scale at 10 days, 6 months and 1 year 2. Shoulder function assessment using Oxford Shoulder Score and Shoulder Goniometry at 24 hours, 48 hours, 10 days and 6 months 3. Incidence and severity of nausea and vomiting 4. Requirement for post-operative anti-emetic 5. Surgical complications, e.g., seroma/infection 6. Patient satisfaction at 10 days 7. Analgesia requirements at 6 months 8. Requirement for re-operation due to complication 9. Duration of post-operative hospital stay |
| Overall study start date | 01/01/2008 |
| Completion date | 01/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 70 |
| Key inclusion criteria | Female patients over the age of 18 who are scheduled for elective single side mastectomy with axillary surgery at Royal Cornwall Hospital Trust will be recruited. |
| Key exclusion criteria | 1. Concurrent enrolment in any other study/trial 2. Pregnancy 3. Bilateral surgery 4. Primary reconstructive surgery 5. Known allergy or sensitivity to local anaesthetic agents, morphine, paracetamol or ondansetron 6. Chronic opioid or non-opioid analgesic use 7. Inability to give informed consent 8. Inability to understand or use a patient-controlled analgesia (PCA) device 9. Inability to understand or complete the visual analogue assessment tools |
| Date of first enrolment | 01/01/2008 |
| Date of final enrolment | 01/06/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Cornwall Hospital Trust
Truro, Cornwall
TR1 3LJ
United Kingdom
TR1 3LJ
United Kingdom
Sponsor information
Royal Cornwall Hospital Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Cathryn Love-Rouse
Senior Manager Research and Development
Research and Development Directorate
Knowledge Spa
Truro
TR1 3HD
England
United Kingdom
| Website | http://www.cornwall.nhs.uk/RCHT/Home.aspx |
|---|---|
"ROR" |
https://ror.org/026xdcm93 |
Funders
Funder type
Government
Royal Cornwall Hospital Trust (UK) - NHS clinical trial using existing resources
No information available
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 | Not provided at time of registration |
| IPD sharing plan |
